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Evidence-Based Series 12-10 A Quality Initiative of the Program in Evidence-Based Care (PEBC), Cancer Care Ontario (CCO) Regional Models of Care for Systemic Treatment T. Vandenberg, M. Trudeau, N. Coakley, J. Nayler, C. DeGrasse, E. Green, J.A. Mackay, C. McLennan, A. Smith, L. Wilcock, and the Regional Models of Care Systemic Treatment Project Team Report Date: May 22, 2007 An assessment conducted in November 2015 deferred the review of Evidence-based Series (EBS) 12-10, which means that the document remains current until it is assessed again next year. The PEBC has a formal and standardized process to ensure the currency of each document (PEBC Assessment & Review Protocol) This EBS is comprised of 3 sections and is available on the CCO Website on the PEBC Systemic Treatment page. Section 1: Standards for the Organization and Delivery of Systemic Treatment Section 2: Evidentiary Review Section 3: Development and External Review—Methods and Results For information about the PEBC and the most current version of all reports, please visit the CCO website at http://www.cancercare.on.ca/ or contact the PEBC office at: Phone: 905-527-4322 ext. 42822 Fax: 905-526-6775 E-mail: [email protected] Guideline Citation (Vancouver Style): T. Vandenberg, M. Trudeau, N. Coakley, J. Nayler, C. DeGrasse, E. Green, et al. Regional models of care for systemic treatment. Toronto (ON): Cancer Care Ontario; 2007 May 22 [2011]. Program in Evidence-based Care Practice Guideline Report No.:12-10. EBS 12-10 Evidence-Based Series #12-10: Section 1 Regional Models of Care for Systemic Treatment: Standards for the Organization and Delivery of Systemic Treatment T. Vandenberg, M. Trudeau, N. Coakley, J. Nayler, C. DeGrasse, E. Green, J.A. Mackay, C. McLennan, A. Smith, L. Wilcock, and the Regional Models of Care Systemic Treatment Project Team A Special Project of the Systemic Treatment Program, Cancer Care Ontario, and The Program in Evidence-based Care, Cancer Care Ontario Report Date: May 22, 2007 Question What is the best way to organize the delivery of ambulatory systemic treatment in Ontario? Rationale for a Standards Document Rapidly expanding indications for systemic treatment, combined with human resource and facility constraints, require an innovative approach to organizing and delivering cancer care in Ontario. The purpose of this document is to provide a practical framework that will guide the standardized delivery of evidence-based systemic treatment province-wide, in hospitals beyond the confines of regional cancer centres. The primary goal of the framework is to provide safe, evidence-based systemic cancer treatment, maximizing the efficient use of resources and employing the principle of patient-centred care with an emphasis on providing care as close to home as possible. Service provision, complexity of care, safety, accessibility, and quality care across all levels defined from the patient, organization, and system perspective, as well as appropriateness, transparency, and accountability, were all taken into consideration. Because education ties in with many of the safety elements, while research ties in with complexity, quality, and education, both are an integral part in the regional delivery of systemic treatment. Scope of Report The following report, developed by the Regional Models of Care Systemic Treatment Project Team, applies to the organization and structure of systemic treatment programs in Ontario. The standards apply to all institutions and programs delivering ambulatory systemic treatment within the province of Ontario and address the following elements: types of providers and their roles, education of providers, service type/complexity, service volumes, quality assurance and safety, facility requirements, and administrative and organizational responsibilities. Geographically dispersed and rural areas may require innovative strategies such as advanced practice roles and remote support to achieve the standards. STANDARDS – page 1 EBS 12-10 Development of the Standards Document Evidence on the current organization and delivery of systemic treatment across Ontario, Canada, the United Kingdom, Australia, and New Zealand was gathered through a systematic search of the literature and a scan of documents from organizations concerned with systemic treatment quality practice. The Regional Models of Care Systemic Treatment Working Group, which included medical oncologists, a Cancer Care Ontario Regional Vice President, a regional cancer program administrator, a systemic treatment satellite nursing administrator, oncology nurses, administrators, pharmacists, and other professionals, reviewed the evidence and developed the standards for Ontario, using a combination of evidence-based analysis, existing recommendations from other jurisdictions, and expert opinion based on experience and consensus. Due to the low quality of available research evidence, these standards are largely based on expert opinion informed by existing standards and recommendations from other jurisdictions. The standards were developed to accommodate long-range needs and take into account the projected increase in systemic treatment needs over the next decade due to a growing and aging population. More importantly, these standards were developed with the expectation of increasing accessibility to safe, quality care. Regional Models of Care for Systemic Treatment The planning and performance monitoring of cancer services is the responsibility of the Regional Cancer Programs (RCPs) that have been established by Cancer Care Ontario (CCO) in each provincial Local Health Integrated Network (LHIN). Through the Regional Vice President, Cancer Services, the RCP advises CCO as to the appropriate distribution of services and is the primary mechanism through which existing and new CCO quality and access standards for cancer services are implemented and monitored. The RCP includes the Integrated Cancer Program (ICP) for the LHIN, which is located at one host hospital, other hospitals and healthcare agencies, and health care providers involved in the delivery of cancer services. The RCP comprises clinical and prevention programs associated with the various phases of care, each linked to a CCO provincial program. One component of each RCP is a Regional Systemic Treatment Program (RSTP), lead by the Regional Head, Systemic Treatment and linked to the CCO provincial program for systemic treatment. The Regional Systemic Treatment Program responsibility is to plan for and facilitate the implementation of the CCO standard outlined in this document. The RSTP will bring together the partners responsible for systemic treatment care delivery to develop a regional plan for implementation of this standard. The RSTP will then work with its regional partners to support the implementation, with additional support from the CCO provincial program in systemic treatment. The Regional Model for Quality Systemic Treatment (Figure 1) consists of a key set of fundamental elements and regional programs designed to implement, monitor, and evaluate quality indicators related to the delivery of safe, evidence-based, and patient-centred care. The Model is an organizational framework for the delivery of systemic treatment within a RSTP. The main goal of the Model is to facilitate the provision of the appropriate care in the appropriate setting within the appropriate timeframe for all patients, regardless of where a patient receives systemic treatment. The Model is comprised of three integrated structures: Integrated Cancer Programs (ICPs), affiliate institutions, and satellite institutions, each with a defined scope of practice. The ICPs are multidisciplinary organizations that provide complex cancer care. Affiliate institutions have their own systemic treatment programs, although they are linked through formal agreements with the RSTP. Satellite institutions have fewer oncology-related resources and have a formal linkage to the RSTP for support in delivering systemic treatment. All regional partner institutions will participate in the development of their RSTPs and will collaboratively determine the appropriate configuration of their model, including the formal STANDARDS – page 2 EBS 12-10 linkages that will be required among institutions. The complexity of care delivered in each type of institution may vary; standards encompassing four levels of care (1-4) are recommended for the delivery of systemic treatment in Ontario. It is the level of complexity and the availability of services that differentiate one level from another. The Regional Systemic Treatment Program determines the appropriate level of care for each institution. Levels are hierarchical, with the satellite responsibilities encompassed within the affiliate and ICP levels. The designation of a level requires an institution to meet all the standards for that level. As individual institutions expand or focus their services, the configuration of the model and designation of institutional levels may change over time, following consultation between the RSTP and the institution. Adapted from: Champlain Regional Cancer Surgery Model, 2006. The successful implementation of the standards is intended to create sustainable, accessible, quality care and improve measurable patient outcomes. These four levels include: Level 4 (Satellite): Provides ambulatory facilities, nursing, pharmacy, and physician support for the administration of low-risk to high-risk, intravenous systemic treatment under the direction of an oncologist from an ICP or affiliate level 3 institution. Systemic treatments given under the supervision of a physician with appropriate training in oncology. Requires access to specialized services and providers with a formalized linkage to the RSTP. STANDARDS – page 3 EBS 12-10 Level 3 (Affiliate): Systemic treatments given under direct supervision of an on-site staff medical oncologist, hematologist, or gynecologic oncologist. Limited teaching and research responsibilities. Level 2 (ICP): Systemic treatments given at an ICP with radiation treatment services and capable of providing most complex systemic treatments, including concurrent head and neck chemoradiation and/or radiolabelled conjugates. Limited teaching and research responsibilities. Level 1 (ICP): Academic institutions with teaching and research responsibilities. Experimental Investigational New Drug (IND) Program (IND phase 1 and or 2 trials with highly developed clinical trials infrastructure, e.g., participate in the National Cancer Institute of Canada Clinical Trials Group [NCIC-CTG] IND program and Princess Margaret Hospital/National Institute of Health [PMH/NIH] new drug consortium) Responsible for training future health care professionals, including oncologists (subspecialty residents and fellows). Standards for Systemic Treatment The goal of the RSTP is to ensure safe, standardized, evidence-based care across the regions. To ensure equitable access to systemic treatment, the following tables delineate the required standards by level in the following areas. Definitions for key terms are provided at end of this section. The following table provides an example of some key differentiating features. However, an institution is required to meet all the standards at a level to be designated at that level. (See Tables 1-7) Complexity Experimental Investigational New Drug Program Concurrent Head and Neck Chemorads and/or Radiolabelled Conjugates Oncologist on Site Determines Treatment Plan All other Systemic Treatment Level 1 (ICP) Level 2 (ICP) Level 3 (Affiliate) Level 4 (Satellite) X X X X X X = yes, X = no Chemorads = chemotherapy + radiation therapy STANDARDS – page 4 EBS 12-10 Table 1. Standards for health care providers and their roles. All levels of care: Where the Standard identifies that services are to be provided in a multidisciplinary environment, all providers required for the service at a particular level are available or readily accessible. All patients being considered for systemic treatment must be assessed by an oncologist. All treatment plans are recommended and parenteral systemic treatment prescribed by the consulting oncologist. Individual treatments as part of an approved course may be ordered by a family physician or internist with oncology training. Ongoing care must be coordinated with the consulting oncologist. Only Registered Nurses with appropriate chemotherapy certification may administer parenteral drugs. Only pharmacists or pharmacy technicians will prepare systemic treatment. Level 4 (Satellite) Level 3 (Affiliate) Level 2 (ICP) Level 1 (ICP) Oncologists - Access to oncologist from a level 1, 2 or 3 hospital required to - Oncologist(s) on staff and Level 3 plus: Level 2 plus: determine and recommend the treatment plan, to manage disease on site. - Developed specific sub- Academic responsibilities status, and to discuss patient management issues with the health - Mentoring family specialized practices. including teaching and care team. physicians / internists. research. - Limited teaching and research. Family - Supervise IV systemic treatment administration with one on site Same as level 4. Same as level 3. Same as level 2. physicians / or readily available (within 15 minutes) during the drug Internists administration time. - Consult oncologist regarding patient management issues (e.g. dose alteration). - Assess and manage toxicity. - Participate in education programs related to the management of patients receiving systemic treatment. Nurses - Administer systemic treatment including monitoring and Level 4 plus: Level 3 plus: Same as level 2. intervening for side effects and reactions, and provide supportive -Plans to implement -Specialized oncology care to the patient. Advanced Oncology Nurse. nurses working towards the - Provide patient education related to planned systemic treatment, national certification in collaboration with pharmacist and physicians. CON(C)* within five years of - Communicate with ICP or affiliate team members and employment. collaborating with supervising physicians as necessary. - Advanced Oncology Nurse - Manage symptoms. to manage selected patient populations independently or inter-dependently with oncologists. Pharmacists - Review and verify systemic treatment orders and supervise the Same as level 4 Level 3 plus: Same as level 2. preparation and dispensing of systemic treatment. - ICP pharmacists provide - Consult with ICP or affiliate pharmacist as required. support and consultation to - Pharmacist or pharmacy technician manages the new drug regional systemic treatment funding program reimbursement process. program. - Provide patient education related to medications in collaboration - Dedicated oncology with nurses and physicians. pharmacists provide clinical - Supervise/manage dispensing and documentation of clinical services. trials. Pharmacy - Prepare systemic treatment under supervision of a pharmacist. Same as level 4. Same as level 3. Same as level 2. technicians Abbreviations: Advanced Practice Nurse prepared at the Master’s level ICP – integrated cancer program; IV – intravenous; CON(C) Certified Oncology Nurse (Canada). STANDARDS – page 5 EBS 12-10 Table 2. Standards for the education of health care providers. All levels of care: Minimum standards are met for orientation and annual continuing education/mentoring in systemic treatment for all staff working in oncology services. Providers are competent to provide the designated level of service and have ongoing education to maintain that competence. Registered nurses meet organizational policy and standards to be certified in chemotherapy administration. Level 4 (Satellite) Level 3 (Affiliate) Level 2 (ICP) Level 1 (ICP) Oncologists - Ongoing CME as per Royal Same as level 3. Same as level 2. College of Physicians and --Surgeons of Canada. - Participation in multidisciplinary cancer conferences as required. Family - Initial orientation and annual Continuing Same as level 4. Same as level 3. Same as level 2 physicians/ medical education. Internists - Mentoring should be available by an oncologist. - Relevant training for systemic treatment being delivered. - Knowledge of CCO regional systemic treatment guidelines and standards and regional policies and procedures. - Participation in multidisciplinary cancer conferences as required. Nurses - Registered nurse certified for the delivery Level 4 plus: Level 3 plus: - Same as level 2 of systemic treatment. - Registered Nurse specialized in - Specialized Oncology Nurses - Working towards CON(C) and/or reoncology, certified in systemic working towards CON(C); certification. treatment administration, and certification should be obtained - Central venous access device annually updated in guidelines and within 5 years of new employment. management education and selection, procedures. - Advanced Oncology Nurse certification. Annual update required. - Plans to implement Advanced (Clinical Nurse Specialist or Acute - Oriented to and practicing according to: Oncology Nursing roles. Care Nurse Practitioner, Master’s CCO Telephone Practice Guidelines preparation) with additional CCO Safe Handling of Cytotoxic Agents knowledge and skills in managing Standards patients on systemic treatment. CCO CVAD Guidelines. - Additional education for nurses - Participation in multidisciplinary cancer managing transplant patients. conferences encouraged. - Additional ongoing education required to match treatment type and complexity. STANDARDS – page 6 EBS 12-10 Pharmacists Pharmacy technicians - Specialized training in oncology. - RSTP should provide a training or certification program for staff involved in the handing of cytotoxic agents and have a policy on re-training. This may be done at or in collaboration with an ICP or Affiliate institution. -Training may include institutional training/orientation program for oncology pharmacists, continuing education programs or courses, oncology pharmacy review courses (e.g. ASHP Oncology Review course), preceptorship programs. - Specialized training in the preparation systemic treatment doses. - RSTP should provide a training or certification program for staff involved in the handing of cytotoxic agents and have a policy on re-training. This may be done at or in collaboration with an ICP or Affiliate institution. Same as level 4. Same as level 3. Same as level 2. Same as level 4. Same as level 3. Same as level 2. Abbreviations: CCO – Cancer Care Ontario; CME – continuing medical education; CON(C) – Certified in Oncology Nursing (C)anada (www.cna-aiic.ca); CVAD – central venous access devices; ICP – integrated cancer program. ASHP – American Society of Health-System Pharmacists STANDARDS – page 7 EBS 12-10 Table 3. Standards for service type and complexity. All levels of care: Services are provided in the most appropriate setting where patients can be assured the best quality outcomes. Each level has access to the other levels where necessary, for consultation or transfer for service delivery. Level 4 (Satellite) Level 3 (Affiliate) Level 2 (ICP) Level 1 (ICP) Service type Please see appendices 1.1-1.3 below for disease site specific CCO core and core restricted regimens As per appendix. Complexity Patient education Supportive care Clinical trials Low to high complexity - Assessment for, management and coordination of central venous access devices (such as PICC or port-a-cath). - Drugs with a high risk of hypersensitivity reaction at first dose will only be given at level 4 centres as agreed upon by the RSTP. - Delivery of systemic treatment in presence of co-morbidity or significant organ dysfunction that increases risk of toxicity and need for dose adjustments, if agreed upon by RSTP. - Monitoring and management of hypersensitivity reactions. - If possible, on site patient education program that meets the CCO standards. Same as level 4 Plus: - Delivery of first dose high risk drugs - Access to supportive care services to address specific patient needs. Same as level 4. Same as level 4 Plus: - adhere to CCO patient education standards As per appendix plus: - Concurrent chemo/radiation. - Radiopharmaceuticals. High complexity Level 3 plus: - Provision of on site direct coordination and supervision of medical and radiation treatment. - Pathological consultation on site. Same as level 2. Level 3 plus: - Patient education program related to radiation treatment - Comprehensive supportive care expertise as part of the ICP. Same as level 3 Level 2 plus: Same as Level 2 Same as level 2. - Specific clinical trial Same as level 2 plus: education for patients IND program with phase 1 and health care and or 2 drugs providers. - Clinical Trials including phase 2 and 3 Abbreviations: CCO – Cancer Care Ontario; ICP – integrated cancer program. PICC – peripherally inserted central catheter. RSTP – Regional Systemic Treatment Program - If Clinical trials are given at the institution, they must be under direction of oncologist. - Family physicians or internists with oncology training may be coinvestigators. - Specific clinical trial education for patients and health care providers. STANDARDS – page 8 EBS 12-10 Table 4. Standards for service volumes. All levels of care: There is sufficient patient volume at the location to maintain competency and skills of professional providers to address the acuity and complexity of the treatment modalities and/or to provide cost-effective use of resources and drugs. (Refer to Discussion in Section 2 of this report). The number of patients that can be treated will be affected by the complexity of treatment regimens. Staffing must be sufficient to provide safe quality care at all times, including during vacation, illness, etc. Table 5. Standards for quality assurance and safety. All levels of care: Cancer care includes management of complications of therapy. All centres will follow CCO’s Safe Handling of Cytotoxic Agents Standards. Up to date guidelines from the Regional Systemic Treatment Program are available for staff for relevant disease sites and relevant symptom management. Training and guidelines include management of oncology emergencies. Access to specialized centres (ICP level 1 or 2 or Affiliate 3) for support of quality and standards. Provision of systemic treatment in the most effective manner. Level 4 (Satellite) Level 3 (Affiliate) Level 2 (ICP) Level 1 (ICP) Safe handling - Policies and educational programs available Same as level 4. Same as level 3. Same as level 2. for all staff involved in systemic treatment including storage, transport, spill management, preparation, administration, and waste disposal. Patient - Patient safety program that includes review Same as level 4. Same as level 3. Same as level 2. outcomes of all medication adverse events and system improvement. Quality Indicators: - Assessment of toxicities and documentation of adverse reaction. Organization - Multidisciplinary cancer conference Level 4 plus: Same as level 3. Same as level 2. outcomes participation encouraged (in line with CCO - Multidisciplinary cancer standards) conference participation required. Quality Indicators: - Track volume of patients treated. - Other indicators such as monitoring adherence to guidelines. System Quality Indicators: Level 4 plus: Same as level 3. Same as level 2. outcomes - Percentage of patients treated close to home. - Monitoring systemic treatment wait times according to CCO Standards. Abbreviations: CCO – Cancer Care Ontario, ICP – integrated cancer program. STANDARDS – page 9 EBS 12-10 Table 6. Standards for facility requirements. All levels of care: The necessary infrastructure is in place to provide the service level. Level 4 (Satellite) Level 3 (Affiliate) Level 2 (ICP) Clinic space - Dedicated systemic treatment area adequate for volume of treatment Same as Level 4. Same as Level 3. visits. - Adequate space to provide clinical trials if applicable. Clinic - Computer, fax and phone accessibility. Same as Level 4 Same as Level 3. equipment - Computer software available to provide computerized physician order entry. Systemic - Oxygen. Same as Level 4. Same as Level 3. treatment and - Biological Safety Cabinet (class 2) and externally vented. facility safety - Appropriate tubing, luer-lock syringes. equipment - IV equipment for parenteral therapy. - IV equipment for ambulatory or inpatient infusional therapy (pumps). - Personal protective equipment for staff who are handling systemic treatment or waste. - Spill kits and supplies for decontamination. - Emergency resuscitation equipment (e.g. crash cart, other emergency supplies, drugs, oxygen and suction) in case of cardiorespiratory arrest or anaphylaxis. - Supportive drugs for treatment of extravasation. - Designated clinical trial storage if doing clinic trials. Institutional - Emergency department. Same as Level 4 plus: Level 3 plus: facilities - Pharmacy for secure storage and preparation of systemic treatment - Intensive Care Unit and - Radiation therapy drugs. specialized Diagnostic services on site. - Access to inpatient beds for oncology patients. imaging onsite - Pathology services on - Access to local specialized diagnostic imaging (CT, US, nuclear site. medicine) and laboratory tests / pathology for monitoring of systemic - On site MRI. treatment. - Specialized diagnostic - Access to Intensive Care Unit. imaging on site. - Access to facility for insertion of central venous catheters/port-a-caths. - Potential for videoconferencing, remote web-based teaching, and patient management as part of MCC. Abbreviations: CT – computed tomography; ICP – integrated cancer program; IV – intravenous; MCC – multidisciplinary cancer conference; MRI resonance imaging; US – ultrasound. STANDARDS – page 10 Level 1 (ICP) Level 2 plus: - Dedicated clinical trials infrastructure onsite Same as Level 2. Same as Level 2. Same as level 2. – magnetic EBS 12-10 Table 7. Standards for administrative and organizational responsibilities. All levels of care: Should measure common provincial indicators May also measure regional indicators as defined by the RCP. Level 4 (Satellite) Data reporting requirements - Outcome indicators that are specific, measurable, attainable/achievable/action oriented, relevant, time-framed (SMART) (3). - Decision support resources to collate and analyze quality indicators. Leadership - Physician and administrative leads identified with defined roles to manage strategic and operational issues through regional forums. - Formal linkage to a Regional Systemic Treatment Program. - Nursing and pharmacy administrative leads identified with defined roles to manage strategic and operational issues through the Regional Systemic Treatment Program. Logistical support - Clerical staff and clinic facilities to support patient scheduling, health record management, and clinic management including clinic and administrative supplies for systemic treatment suites and ambulatory clinic visits. Information systems - Information system hardware and support to maintain a secure electronic systemic treatment order/entry program and other electronic systems as indicated (e.g., electronic patient record). Abbreviations: ICP – integrated cancer program. Level 3 (Affiliate) Level 2 (ICP) Level 1 (ICP) Same as level 4. Same as level 3 Plus: - CCO data book compliant Same as level 2. Level 4 plus. - May have formalized linkages with a satellite. level 3 plus: - Regional vice president and regional systemic treatment leads. Same as level 2. Same as level 4. Same as level 3. Same as level 2. Same as level 4. Same as level 3. Same as level 2. STANDARDS – page 11 EBS 12-10 DEFINITIONS Advanced Oncology Nurse – The Advanced Oncology Nurse is prepared at the Master’s level (MScN or equivalent). Ideally, the graduate program would be focused in oncology nursing, likely with a particular emphasis on a subpopulation or area within cancer control such as prevention, screening, and counselling or a theme within cancer care such as coping, psychosocial care, and counselling. Theoretical knowledge in nursing and other sciences grounds the nurse in the advanced provision of care to individuals, their families, and the communities within which cancer care is given. Additional certification as an Acute Care Nurse Practitioner, or other levels, may be acquired either within the Graduate Program or as a postgraduate course and certification. The domains of the Advanced Oncology Nurse include the following: advanced clinical practice education research scholarly/professional leadership organizational leadership (4) Certification in Systemic Treatment Administration (Certified in Chemotherapy) – No registered nurse in Ontario should administer intravenous systemic treatment until and unless they have received additional education and have demonstrated competency in the delivery of these cytotoxic agents. This requirement is specific to the delivery of chemotherapy and is not to be confused with the national examination process for Certification as an Oncology Nurse through the Canadian Nurses Association. Complexity – Determined by the preparation and administration requirements for systemic treatment, risk of immediate grade 3/4 toxicities, medical condition of the patient, or use of investigational agents or new agents just approved for which there is little long-term toxicity data. ICP: Integrated Cancer Program – A multidisciplinary in and out patient cancer program including medical, radiation and surgical oncology. The ICP will also provide research, education and organizational leadership for the RCP. Institutional Facilities – Hospitals, clinics or offices as outlined in the facility requirements element. Local Health Integration Networks (LHINs) – The purpose of these regional districts is to build a system that is focused on the needs of the local community and provides integrated, safe, and high-quality services to meet those needs (1). Oncologist – A physician with subspecialty training in the administration of systemic treatment, recognized by the Royal College of Physicians and Surgeons of Canada, including medical oncologists, hematologists and gynecologic oncologists. Quality indicator – A specific, measurable, attainable, relevant, time-framed outcome from the patient, organizational, or system perspective to assess performance (3). Regional Cancer Program (RCP) – Links together cancer providers and organizations across the spectrum of cancer care. STANDARDS – page 12 EBS 12-10 Regional Systemic Treatment Program (RSTP) – An agreed-upon relationship between satellites, affiliates, and ICPs. Specialized Oncology Nurse – A nurse who has a combination of expanded education focused on cancer care and experience such as two years in a setting where the primary focus is cancer care delivery. The Specialized Oncology Nurse might acquire specialty education through a variety of ways, for example, enrolment in an undergraduate nursing program, completion of an Oncology Certificate Program, distance specialty education (such as offered in Adult and Pediatric Oncology Nursing), or registration in and completion of the certification exam offered by the Canadian Nurses Association and attainment of the distinction Certified in Oncology Nursing (C)anada CON(C). The Specialized Oncology Nurse works in a specialized inpatient setting such as an oncology unit or bone marrow transplant unit; an ambulatory setting focused on the delivery of cancer care; a screening program; or a supportive care setting or community setting offering palliative care. There are many environments where the enhanced specialty knowledge and skill can be utilized to manage symptoms and side effects of treatment, counsel patients in coping strategies, teach self-care behaviours, and monitor the responses to treatment and nursing interventions. (4) Systemic Treatment – Any oral or parenteral hormonal, biological, chemotherapeutic, or radiopharmaceutical anticancer agent. STANDARDS – page 13 EBS 12-10 For further information about this report, please contact: Dr. Ted Vandenberg London Regional Cancer Program London Health Sciences Centre 790 Commissioners Road London, ON N6A 4L6 Email: [email protected] TEL: 519-685-8640 Dr. Maureen Trudeau Cancer Care Ontario 620 University Avenue Toronto, ON M5G 2L7 Email: Maureen.Trudeau@sunnybrook. ca TEL: 416-480-5145 Funding The PEBC is supported by the Ontario Ministry of Health and Long-Term Care through Cancer Care Ontario. All work produced by the PEBC is editorially independent from its funding source. Copyright This report is copyrighted by Cancer Care Ontario; the report and the illustrations herein may not be reproduced without the express written permission of Cancer Care Ontario. Cancer Care Ontario reserves the right at any time, and at its sole discretion, to change or revoke this authorization. Disclaimer Care has been taken in the preparation of the information contained in this report. Nonetheless, any person seeking to apply or consult the report is expected to use independent medical judgment in the context of individual clinical circumstances or seek out the supervision of a qualified clinician. Cancer Care Ontario makes no representation or guarantees of any kind whatsoever regarding their content or use or application and disclaims any responsibility for their application or use in any way. Contact Information For information about the PEBC and the most current version of all reports, please visit the CCO website at http://www.cancercare.on.ca/ or contact the PEBC office at: Phone: 905-527-4322 ext. 42822 Fax: 905-526-6775 E-mail: [email protected] STANDARDS – page 14 EBS 12-10 REFERENCES 1. Government of Ontario. Local Health Integration Networks [homepage on the Internet]. 2006 [cited 2006 Apr 17]. Available from: http://www.lhins.on.ca/english/main/home.asp 2. Cancer Care Ontario. Ontario Cancer Plan 2005-2008 [monograph on the Internet]. 2004 [cited 2006 Apr 17]. Available from: http://www.cancercare.on.ca/documents/OntarioCancerPlan.pdf 3. Project Smart. Smart Goals [monograph on the Internet]. 2006 [cited 2006 Nov 27]. Available from: http://www.projectsmart.co.uk/smart_goals.html 4. Canadian Association of Nurses in Oncology. Standards of care, roles in oncology nursing and role competencies [monograph on the Internet]. 2001 [cited 2006 Nov 24]. Available at: http://www.cos.ca/cano/web/en/docs/CANO_CONEP_Standards_AUG01.pdf STANDARDS – page 15 EBS 12-10 Appendix 1.1. Core + core restricted CCO regimens organized by institutional level of care for breast, gastrointestinal, and lung cancer and hematology, as of October 2006. Clinical trial drugs will be given at level 1, 2, or 3 or at level 4 under the supervision of oncologist. Concurrent chemotherapy and radiation may be given at level 3 facilities (for head and neck or lung cancer) or level 3 or 4 facilities (for rectal cancer) with agreement of the RSTP. BREAST GASTROINTESTINAL LUNG HEMATOLOGY Level 4 Adjuvant AC AC-TAXOL AC-TAXOL DD CAF CEF CMF(IV or PO) FEC100 FEC-T TRASTUZ TAMOX ANASTROZOLE LETROZOLE EXEMESTANE Neoadjuvant CAF-T AC-DOCETAXEL LABC/INFLAM AC-DOCETAXEL AC-TAXOL CEF EC-GCSF FEC100 FEC-T Metastatic TAMOXIFEN LETROZOLE ANASTROZOLE EXEMESTANE MEGE FULVESTRANT LHRH analogues +(tamoxifen/AIs) PAMIDRONATE AC FAC FEC CMF DOXO EPI PACLI DOCETAX VINOR CAPECIT-DOCE TRASTUZ+ D/T/V* *T=paclitaxel *D=docetaxel *V=vinorelbine ANUS Adjuvant FU-CISP*LO FU-CISP*HI NSCLC st 1 dose: PACLI ERLOTINIB COLORECTAL Adjuvant 5FU (IV/CIV) 5FU-RT FU-LEUC*LO FU-LEUC*LO-RT CAPEC FOLFOX-4 Adjuvant VINOCISP Metastatic CAPEC BEVACIZUMAB-IFL BEVACIZUMAB-FOLFIRI BEVACIZUMAB-FOLFOX4 FU-LEUC*LO FOLFIRI FOLFOX4 IRINOTECAN RALTITREX ESOPHAGUS FU-CISP*LO FU-CISP*HI GASTRIC Adjuvant ECF ELF FULV Metastatic CISPLATETOP ETOPCARBO DOCETAX PACLITAXEL VINOR GEMCIT DOCECISP PACLICARB PACLICISP VINOCARBO GEMCISP GEMCARBO SCLC CAV CAVEP CISPETOP ETOPCARBO MESOTHELIOMA RALTITREX-CISP PEMETREXED-CISP PANCREAS FU FU*CIV GEMCIT STANDARDS – page 16 CLL CHLORAMBUCIL*PO CHOP CVP FLUDARABINE*PO CML HYDROXYUREA INTERFERON ALFA IFN-CYTARABINE IMATINIB HAIRY CELL LEUKEMIA CLADRIBINE INTERFERON ALFA HODGKIN’S Dx ABVD MINI-BEAM DHAP ESHAP GDP NHL CHOMP CHOP-RITUXIMAB st RITUXIMAB 1 dose RITUXIMAB-MAIN MYELOMA BORTEZOMIB CLODRONATE PAMIDRONATE DEXAMETHASONE*PO MELPH-PRED VAD EBS 12-10 GASTRIC Adjuvant FULV-RT Levels 1, 2, and 3 Locally Advanced CISPETOP-RT VINOCISP-RT ACUTE LEUKEMIA All NHL HYPER-CVAD MAGRATH IBRITUMOMAB For updates and an explanation of the abbreviations, please see the CCO Web site at: http://www.cancercare.on.ca/index_chemoRegimensbyDisease.htm. STANDARDS – page 17 EBS 12-10 Appendix 1.2. Core + core restricted CCO regimens organized by institutional level of care for gynecological, genitourinary, and head and neck cancer and sarcoma, as of October 2006. Clinical trial drugs will be given at level 1, 2, or 3 or at level 4 under the supervision of oncologist GYNECOLOGY GENITOURINARY CERVIX CISP CISPETOP CISP-XRT BLADDER CMV M-VAC M-VAC (high dose) GEM-CISP Intravesical ENDOMETRIUM CARBO CISPDOXO PAC PACLICARBO-UPSC GESTATIONAL TROPHOBLASTIC EMA-CO EP-EMA GERM CELL OVARY CISPETOP PEB PIE HEAD & NECK Level 4 HEAD&NECK Advanced FUCISP METHO SARCOMA EWING’S IE-VAC IFOSDOXO IFOSETOP GIST IMATINIB PROSTATE MITXPRED DOCETAXPRED ZOLEDRONIC ACID KAPOSI’S DOXLIPO ABV AB-VCR IFN-ALFA VINB VINB-VIN RENAL IFN-ALFA TESTIS BEP PIE VIP OSTEOGENIC CISPDOXO IFOS IFOSETOP GESTATIONAL TROPHOBLASTIC DACTIN METHO SOFT TISSUE IFOS IFOSDOXO DOXO DTIC VINBMTX-DES VINOMTX-DES OVARY CARBO CISP PACLICARBO PACLICISP DOXOLIP TOPOTECAN PACLITAXEL UTERINE SARCOMA DOXO OVARY Intraperitoneal chemo RENAL IL-2 SUNITINIB Levels 1, 2, and 3 HEAD&NECK Locally Advanced CISPLO-RT CISPHI-RT NASOPHARYNX CISPFU-RT FUCIS-RT For updates and an explanation of the abbreviations, please see the CCO Web site at: http://www.cancercare.on.ca/index_chemoRegimensbyDisease.htm. STANDARDS – page 18 EBS 12-10 Appendix 1.3. Core + core restricted CCO regimens organized by institutional level of care for CNS and endocrine cancer, melanoma, and Unknown Primary, as of October 2006. CNS/ENDOCRINE MELANOMA Unknown Primary Level 4 BRAIN PROCARB LOMUST CARMUST PCV TEMOZOLAMIDE MELANOMA Adjuvant IFN ALFA IV IFN ALFA sc maintenance Metastatic DACARB BPD CISETOP PEB PLF PLF CAP ADRENAL DOXO CARCINOID DOXO IFN-ALFA THYMOMA EPI VAC Levels 1 and 2 CARCINOID RADIOLABLED OCTREO For updates and an explanation of the abbreviations, please see the CCO Web site at: http://www.cancercare.on.ca/index_chemoRegimensbyDisease.htm. STANDARDS – page 19 EBS 12-10 Evidence-Based Series #12-10: Section 2 Regional Models of Care for Systemic Treatment: Evidentiary Review T. Vandenberg, M. Trudeau, N. Coakley, J. Nayler, C. DeGrasse, E. Green, J.A. Mackay, C. McLennan, A. Smith, L. Wilcock, and the Regional Models of Care Systemic Treatment Project Team A Special Project of the Systemic Treatment Program, Cancer Care Ontario, and The Program in Evidence-based Care, Cancer Care Ontario Report Date: May 22, 2007 QUESTION What is the best way to organize the delivery of ambulatory systemic treatment in Ontario? INTRODUCTION Cancer is a major cause of morbidity and mortality and the leading cause of potential years of life lost in Canada. Increased demands for cancer services are related to annual incidence increases of 3%, mainly due to population growth and aging (1). Medical oncology consultations are increasing 10-20% annually. Systemic treatment has increased at an annual rate of 7-10%, a growth related to the continuing introduction of new evidence-based therapies that improve survival and quality of life (2), and newer treatments lie in the wings (3). These treatments, which are often more complex than those replaced, are delivered for longer periods as the survival time with chronic malignant disease lengthens. Furthermore, the complexity of care, increased patient expectations, and the influence of information available on the Internet all require that more time be spent with the average patient. Continuing manpower shortages contribute to the difficulty of funding and filling new oncology positions (2). The November 2005 Canadian Post-M.D. Education Registry (CAPER) revealed that there are only 34 medical oncology residents and eight fellows in oncology training for the entire country (4). Meanwhile, increasing numbers of physicians are reaching retirement age, and retirements are expected to accelerate, particularly in rural areas (5). Existing facilities are no longer able to support projected increases in demand for cancer care over the next decade (6). The implementation of healthcare restructuring and an increased reliance on alternate healthcare providers such as nurse practitioners and family physicians may pose recruitment problems in some geographic regions. A national report from the Canadian Institute for Health Information (7) suggested that Ontario had one of the oldest registered nurse (RN) workforces in Canada and predicted that the province could lose 12% of that workforce by 2006. The impact of retirements will affect the cancer system, where the majority of certified oncology nurses are in the ambulatory setting. In the face of these changes, Ontario needs to devise innovative ways to deliver safe and effective systemic treatment for people with cancer. The risks of not pursuing a revised and EVIDENTIARY REVIEW – page 1 EBS 12-10 sustainable model of delivery of systemic treatment include the adoption of ad hoc and inconsistent local solutions, the cessation of service in some jurisdictions, and inequalities in access to and standards of care. METHODS A systematic literature search and environmental scan were conducted to find evidence for the best way to organize the delivery of regional systemic treatment in Ontario. The searches yielded the evidentiary base used by the Regional Models of Care Systemic Treatment Project Team (the Panel) (Appendix 1) to facilitate their discussions and inform the recommendations. Evidence Search Strategy The scientific and clinical literature was systematically searched for published and unpublished reports pertaining to the organization and delivery of systemic treatment. Published sources included the medical databases MEDLINE (OVID; 1996 through June 2006), EMBASE (OVID; 1996 through June 2006), CINAHL (OVID; 1996 through June 2006), and HealthStar (OVID; 1996 through June 2006). The following terms were used: “Antineoplastic Agents”, “Chemotherapy”, “Infusions intravenous”, and “Neoplasms”, combined with “Health facilities”, “Organizational policy”, “Continuity of Patient Care”, “Outpatient clinics”, “Ambulatory Care facilities”, “Hospitals Rural”, “Hospitals Community”, “Hospitals General”, “Health Care facilities”, and “Health Care policy”. Article bibliographies and personal files were also searched for evidence relevant to this report Environmental Scan The environmental scan included reviewing published and unpublished sources relating to systemic treatment delivery at hospitals outside a larger cancer centre. In addition to Canada, health care organizations in the United Kingdom (UK), Australia, and New Zealand were chosen by the Panel, because those countries have health care systems that most closely reflect those in place in Canada. A starting point for the environmental scan was the Web sites of the Ministry or Department of Health for each country. The next step involved the Web sites of provincial or district cancer agencies for strategic cancer plans or similar documents pertaining to the organization of systemic treatment in regional centres. The Web sites of cancer centres identified in the provinces or districts were then searched for relevant documents. In addition, key people identified in the documents or Web sites were contacted twice for possible additional information or reports, but those contacts yielded no results. The following Web sites were searched between June 25 and July 4, 2006 for documents pertaining to the organization of systemic treatment: Other provincial cancer agencies in Canada ▪ Albert Cancer Board ▪ British Columbia (BC) Cancer Agency ▪ Cancer Care Manitoba ▪ Cancer Care Nova Scotia ▪ Newfoundland Cancer Treatment and Research Foundation ▪ Saskatchewan Cancer Agency National cancer agencies in the U.K., Australia, and New Zealand ▪ The Cancer Council Australia ▪ The Collaboration for Cancer Outcomes Research and Evaluation (Australia) ▪ National Cancer Control Initiative (Australia) ▪ New Zealand Cancer Control Strategy ▪ New Zealand Cancer Control Trust ▪ Regional Cancer Centre Waikato Hospital, Hamilton, New Zealand ▪ State Government of Victoria, Australia EVIDENTIARY REVIEW – page 2 EBS 12-10 ▪ Peter MacCallum Cancer Centre (Australia) ▪ Medical Oncology Group of Australia ▪ Cancer UK ▪ Cancer Services Collaborative, Avon Somerset and Wiltshire (UK) ▪ Cancer Services Collaborative National Health Service (NHS) Modernisation agency ▪ NHS -National Health Service (UK) Canadian Organizations: ▪ CAPCA (The Canadian Association of Provincial Cancer Agencies) ▪ CAMO (Canadian Association of Medical Oncologists) ▪ CINO (Canadian Intravenous Nurses Association) ▪ CANO (Canadian Association of Nurses in Oncology) A free keyword search between June 25 and July 4, 2006 was done through the Internet search engine Google (©2007 Google), using the following terms: Regional integrated cancer plan (and country was used for each search term) Cancer centre Cancer clinic Cancer services Cancer treatment Chemotherapy administration standards Chemotherapy facility standards Modes of cancer care Multidisciplinary cancer care chemotherapy Rural cancer clinic Satellite cancer clinics Systemic therapy Systemic therapy standards Systemic therapy cancer regional Systemic therapy guidelines The final step in the environmental scan was a search for documents that were mentioned in the text or references of the identified reports. Given the breadth of the information identified by this approach, the selection of documents focused on reports from jurisdictions that were generalizable to Ontario. These included jurisdictions having a government-funded universal health care system with regional rather than hospital-based models of delivery of systemic treatment. Inclusion Criteria For the purposes of this project, the inclusion criteria were kept purposefully broad. For the systematic review, studies published between 1996 and June 2006 were included if they provided any evidence on ways to deliver systemic treatment with ambulatory institutions. Study design and study outcomes were kept open. For the environmental scan, any report that provided information on ways to deliver systemic treatment within ambulatory institutions was included. Exclusion Criteria Articles were excluded if they were published in a language other than English, because translation services were not available. RESULTS An overview of the documents deemed eligible for inclusion is presented in Table 1. The reports provide descriptive organization criteria for administering systemic treatment in an ambulatory setting. EVIDENTIARY REVIEW – page 3 EBS 12-10 Table 1: Documents eligible for inclusion. Environmental Scan Systematic Review Types of providers and their roles Education of providers Service type/complexity Service volumes Quality assurance and safety Facility requirements Administrative and organizational responsibilities Ontario Canada, other than Ontario Number Ref ID Number Ref ID Number Ref ID 8 (8-15) 6 (16-21) 3 3 (9,15,30) 5 (16,21,31 -33) 2 (8,13) 1 4 (10,12,15, 43) 5 United Kingdom Australia New Zealand Number Ref ID Number Ref ID Number (22-24) 3 (25-27) 2 (28,29) 0 5 (22,23,3436) 1 (25) 1 (28,37) 1 (38) (39) 3 (24,40,41) 2 (26,27) 3 (28,29,42) 1 (38) 4 (21,3133) 2 (34,44) 2 (25,27) 0 (8,9,11,30, 45) 5 (16,21,32 ,33,46) 3 (24,34,47) 1 (25) 1 (28) 0 2 (9,15) 4 (16,21,32 ,33) 2 (24,34) 2 (25,48) 1 (28) 0 1 (9) 2 (32,33) 3 (23,24,34) 0 1 (28) 0 EVIDENTIARY REVIEW – page 4 0 Ref ID EBS 12-10 Published Literature Characteristics (Table 2) Overall, the quality of the evidence identified in the literature search was modest. As expected, no randomized controlled trials were found. The six reports located dealt primarily with the delivery of chemotherapy in rural settings (10,12-15,43). Three position papers were also found, of which two were special statements from the American Society of Clinical Oncology (ASCO). One ASCO paper referred to the use of private agencies outside the ambulatory setting to prepare and administer chemotherapy (8), and the other referred to the criteria needed for facilities and personnel in the preparation and administration of systemic antineoplastic therapy (9). The other position paper, from The Cancer Nurses of Australia, outlined the education requirements for nurses administering systemic treatment (30). Two additional papers reported on surveys (14,45), and the final article located was an account of how one health facility instituted a standard for delivering chemotherapy (11). Environmental Scan Characteristics (Table 3) The environmental scan yielded 31 relevant and important documents from 17 institutions and regions, but unpublished documents might exist that have not been identified. Overall, the evidence was still quite modest as no randomized controlled trials were found. Few documents considered or reported on evidence and many provided little detail in their recommendations. Many were expert panel or consensus based, although they did explicitly state how consensus was reached (24-27,29,38,42). The documents primarily consisted of reports providing recommendations on how to improve and effectively deliver cancer services in the community (24-29,34,36-38,40,42,47,48). Two documents reported on survey results (37,48). Four documents were affiliation agreements between central cancer centres and community hospitals delivering systemic treatment (16,21,32,33). Evidence Focus (Table 4) The inclusion of a document for detailed review by the Regional Models of Care Systemic Treatment Working Group (Appendix 1) was based on the merits of the methods behind and relevance of its conclusions (whether it was a consensus or working party report versus a survey, whether or not information was referenced, and whether the system in question was similar to the systemic treatment delivery system in Ontario). The documents were then evaluated based on whether they addressed key program elements (types of providers and their roles, education of providers, service type or complexity, service volumes, quality assurance and safety, facility requirements, or administrative and organizational responsibilities). Based on these criteria, the most relevant documents were chosen to develop a core document outlining the levels of delivery of systemic treatment and the essential or desirable features of the program elements required for each level. The documents from Australia were not chosen as they were mainly based on the availability of surgical and radiation oncology services. The model for Ontario is primarily directed at the provision of systemic treatment services. Table 4 details the key documents chosen from the published literature and the environmental scan by the report Working Group. EVIDENTIARY REVIEW – page 5 EBS 12-10 Table 2: Description of reports identified in published literature. Purpose /Scope Methods Intended Audience 1 2 No No Australian cancer nurses. No No Oncologists who refer patients to outside services to prepare and administer chemotherapy. No No Yes Yes Facilities that are interested in administering antineoplastic therapy. Intended for use in author’s hospital setting. No No Not stated. Yes Yes Health facilities providing chemotherapy in rural areas. No No Not stated. No No Health facilities interested in proving chemotherapy. No No Author’s rural 225 bed hospital. Yes Yes Health facilities and personnel interested in rural cancer services. Yes Yes Findings provide useful framework for cancer services in rural areas. 1 Consensus Minimum requirements nurses PS Yes must have to administer chemotherapy and check list of safety requirements. ASCO (8) To ensure oncologists are aware of PS No (2003) standards for outside agencies that prepare and administer chemotherapy. ASCO (9) Requirements for facilities that PS Yes (2004) want to administer antineoplastic therapy Mahoney (11) The team met to review current C Yes (1998) practices and to identify inconsistencies and make improvements. A consensus was reached and incorporated into the hospitals policy. MacBride (10) Reviews author’s clinic in terms of NA No (1999) what is currently being done when chemotherapy is being administered to patients. McCarthy (45) Provides information on what S Yes (2003) needs be done to ensure patients in rural and remote places have access to proper care. McCavana (12) Reports on how chemotherapy is N/A Yes (2000) being delivered in author’s rural clinic. McLinden (15) Requirements for health facilities N/A Yes (2001) and personnel delivering chemotherapy in a rural setting. Parrish (13) Creation of drug safety check lists N/A Yes (1983) to administer chemotherapy at a rural hospital. Smith (14) Investigates chemotherapy service S Yes (2004) in rural Scotland. Discusses current situation and areas that need improvement. Stevenson (43) To measure consensus and C Yes (2003) priorities among rural health professionals who treat cancer. Abbreviations: C – Consensus; PS – Position Statement; S – Survey. Method Cancer nurses of Australia (30) (2003) References included Type 2 Author Method – report provided description of how evidence was found and used – yes or no. Consensus – report provided description of how conclusions/recommendations were reached – yes or no. EVIDENTIARY REVIEW – page 6 EBS 12-10 Table 3: Description of reports identified in environmental scan. Methods Intended Audience method Consensus To develop a framework of cancer services in the state of Victoria in Australia. Provides information about the organization, structure and programs of the BC Cancer Agency. To create a network of care in England and Wales that will allow a patient to receive treatment close to home. Provides information on service type, roles, quality, facility requirements and administrative duties for health facilities delivering systemic treatment in Nova Scotia. Provides instructions and requirements for facilities delivering systemic treatment associated with the Cancer Centre of Southeastern Ontario. Aim of survey was to map existing cancer services in rural and remote areas in Australia and to compare these with two metropolitan centres in Australia. Provides requirements for facilities delivering systemic treatment associated with Sudbury RCP C Yes No No W No No No C Yes Yes Yes C Yes Yes Yes Systemic treatment programs in Nova Scotia. A No No No S Yes Yes No Hospitals delivery systemic treatment in Southeastern Ontario. Regional hospitals delivering chemotherapy in Australia. A No No No Provides instructions and requirements for facilities delivering systemic treatment associated with the London Regional Cancer Centre A No No No Medical Oncology Group of Australia Incorporated (28) (2001) Ministry of Health (New Zealand) (38) (2006) To provides resources for health care providers involved in cancer in rural and remote areas of Australia To develop cancer treatment strategies for all New Zealanders WP Yes No No G No Yes No National Health Service (UK) (25) (2004) This manual lists what measures/processes need to be in place in an institution delivering systemic treatment Provides instructions and requirements for facilities delivering systemic treatment associated with The Ottawa Hospital Regional Cancer Centre C No No No A No No No To consider workforce implications for clinical and medical oncologists of implementing the recommendations from the Calman-Hine report. Results of survey. Provides ideas on how to make improvements to adult chemotherapy outpatient units. WP Yes Yes Yes S No Yes Yes Anyone wanting to make their chemotherapy unit more patient friendly. Provides information on the structure of the Saskatchewan Cancer Agency. Provided through their Web site. Business plan for delivering chemotherapy in community hospitals in southwestern Ontario. W N/A N/A N/A A No No No Health facilities and personnel in Saskatchewan. Regional hospital in Southwestern Ontario Barton (Australia) (29,42) (2003) BC Cancer Agency (22,36,41,44,49) (2006) Calman & Hine (UK) (26) (1995) Cancer Care Nova Scotia (24) (2005) Cancer Centre of Southeastern Ontario (32) (2005) Clinical Oncological Society of Australia (37) (2006) Hôpital Régional de Sudbury Regional Hospital (21) (2005) London Regional Cancer Centre (16) (2006) The Ottawa Hospital Regional Cancer Center (33) (1998) Royal College of Physicians (UK) (27) (2001) Royal College of Radiologists – Clinical Oncology Patients’ Liaison Group (UK) (48) (2003) Saskatchewan Cancer Agency (23,34,35,40,47) (2006) Southwest Region Cancer Plan (31) (2006) EVIDENTIARY REVIEW – page 7 1 References included 2 Purpose Scope type Author Cancer services in the state of Victoria, Australia. Hospitals and Cancer Centres in BC. Cancer Units and Centres in the UK. Hospitals delivery systemic treatment in Northeastern Ontario. Huron Perth Hospital, Wingham and District hospital and Stratford General Hospital. Health facilities administering systemic treatment in Australia. Health facilities caring for cancer patients in New Zealand. Health facilities delivering cancer care in the UK. Hospitals delivering chemotherapy as a satellite of The Ottawa Hospital Regional Cancer Centre in Champlain LHIN. Cancer Units and Centres in the UK. EBS 12-10 Intended Audience Consensus No No No 1 A Health care facilities in Ontario associated with the Northwestern Ontario Regional Cancer Centre. Abbreviations: A – agreements; BC – British Columbia; C – consensus; G – Government Report; LHIN – Local Health Integration Network; PS – Position Statement; S – Survey; UK – United Kingdom, W – Web Site; WP – Working Party Report. 1 2 Provides instructions and requirements for facilities delivering systemic treatment in Northwestern Ontario. method 2 Methods References included Thunder Bay Regional Health Science Centre (17-20,39,46) (2006) Purpose Scope type Author Method – report provided description of how evidence was found and used – yes or no. Consensus – report provided description of how conclusions/recommendations were reached – yes or no. EVIDENTIARY REVIEW – page 8 EBS 12-10 Table 4: Coverage of program elements by reports. Providers and their roles Cancer Care Nova Scotia Levels of Care for Cancer Systemic Therapy in Hospitals (24) (2005) BC Cancer Agency (22,36,41,44,49) (2006) Saskatchewan Cancer Agency (23,34,35,40,47) (2006) Thunder Bay Regional Health Science Centre (1720,39,46) (2006) Royal College of Physicians (UK) (27) (2001) London Regional Cancer Centre (16) (2006) Hôpital Régional de Sudbury Regional Hospital (21) (2006) Cancer Centre of Southeastern Ontario (32) (2005) The Ottawa Hospital Regional Cancer Centre (33) (1998) ASCO (9) (2004) Calman-Hine A policy framework for Commissioning Cancer Services (26) (1995) National Health Service Manual for Cancer Services (UK) (25) (2004) Education of providers X Service type / complexity Service volumes X X X X X X X X X X X X X X X X X X Facilities Administrative and organizational responsibilities X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X QA/ Safety X X X Abbreviations: ASCO – American Society of Clinical Oncology; BC – British Columbia; QA – quality assurance; UK – United Kingdom PROGRAM ELEMENTS Neither the published literature nor the environmental scan yielded any evidence demonstrating superior patient outcome (e.g., survival, quality of life) as a function of the service model (e.g., service, volume). This does not mean a relationship does not exist; rather, this phenomenon has not been studied and reported. The affiliation agreements selected reflect current Ontario practices, although few referenced the evidence for or described the methods behind the development of agreement requirements. Types of Providers and Their Roles Published Literature Eight reports (Table 5) provided information on the relevant provider roles (8-15). Four reports provided a description of the role of the oncologist, but these were not very detailed. The role of the oncologist was primarily to prescribe the systemic treatment and to be in the facility in case of an adverse reaction. All the reports except one provided information on the roles of nurses administering chemotherapy, roles that were clearly defined and consistent from report to report. A common theme throughout all the documents was the need for appropriate training for nurses and pharmacists. The role of the pharmacists was described in four reports, with the EVIDENTIARY REVIEW – page 9 EBS 12-10 roles being clearly defined and similar in all four. Certification in preparing and handling cytotoxic agents was a requirement for all pharmacists. Two reports provided fairly consistent definitions for the role of the general practitioner, which was mainly to administer chemotherapy in difficult cases and to care for patients. While the role of other support staff was only mentioned in one article, their role is clearly defined in this present report. Environmental Scan Eight reports (Table 6) contained information on providers and their roles (22-29). All the reports clearly defined the roles of nurses administering chemotherapy, and the role descriptions were consistent between reports. Five reports provided a description of the role of the oncologist, but this was not very detailed and varied between reports. The role of the pharmacists was described in five documents, with their roles being clearly defined and similar in all the reports. Certification in preparing and handling cytotoxic agents was a requirement for all pharmacists. Only four reports defined the role of the general practitioner, but the role description was fairly consistent between reports and was mainly to be available for chemotherapy emergencies. The role of other support staff was only mentioned in two reports, but was clearly defined in both. Environmental Scan - Ontario Reports were available from three Ontario regions (Table 6) (16-21). The roles of the medical oncologist from the Regional Cancer Program (RCP) and the role of the community physician were clearly defined. The oncologist in the RCP was to prescribe the treatment and the community physicians were to monitor the patient during that treatment. The role of the nurses was only discussed by one region, but because the documents had very defined sections on nursing education and training, it could be understood that nurses were to deliver the systemic treatment. Neither the role of the pharmacist nor of administrative or other support staff was discussed. EVIDENTIARY REVIEW – page 10 EBS 12-10 Table 5: Providers and their roles – published literature. Report (reference) ASCO (8) (2003) ASCO (9) (2004) Oncologists Nurses Appropriately trained physician should be present when a potentially anaphylactic drug is being administered. Only qualified physicians should prescribe antineoplastic therapy. Physicians should also supervise nurses administering antineoplastic therapy. Should have specific training to administer chemotherapy. MacBride (10) (1999) Mahoney (11) (1998) McCavana (12) (1998) Only oncologists shall prescribe antineoplastic therapy. Can administer chemotherapy if have training and through intrathecal route. Visiting oncologist, lead cancer clinician provides care to rural community hospital. Pharmacists General practitioners Should be qualified to administer antineoplastic therapy. Can practice expanded roles e.g., cytotoxic administration, venipuncture, and access skin-tunnelled catheters. Can make decisions based on approved protocols. Antineoplastic agents can only be administered by specially trained nurses and only through approved routes. Clinic operated by Macmillan clinical nurse specialist and oncology trained ward sister. Parrish (13) (1983) Adequate support staff required to maintain supplies, schedule patients, and complete paper work. Prepares the antineoplastic agents onsite and adheres to safe handling procedures. Team includes specially trained pharmacist. Prepares medication, takes patient medication history and educates patient on side effects. Smith (14) (2003) Chemotherapy mainly delivered by specialist nurses. Some ward staff and nurses trained in administration were also utilized in the clinics. McLinden (15) (2001) Nursing staff trained in chemotherapy administration administer the systemic treatment. Other support staff GP’s with training in advanced chemotherapy procedures care for patients at outreach clinics and administer chemotherapy if patients very ill. Two family physicians with oncology training from cancer centre help care for chemotherapy patients at the hospital. Prepares medication; if a properly trained pharmacist is not available a pharmacy technician or physician can be trained to mix the agents. Abbreviations: ASCO – American Society of Clinical Oncology; GP – General Practitioner. EVIDENTIARY REVIEW – page 11 EBS 12-10 Table 6: Providers and their roles – environmental scan. Report (reference) Oncologists Nursing Pharmacists Cancer Care Nova Scotia (24) (2005) Clear roles defined in five different levels of cancer care. Clear roles defined in five different levels of cancer care. Clear roles defined in five different levels of cancer care. Only nurses recognized by the Saskatchewan Cancer Agency as being certified in chemotherapy administration may administer treatments. Must be licensed and have completed chemotherapy certification course. Responsible for preparation and disposal of cytotoxic agents. Certified chemotherapy nurse must record 50 chemotherapy administrations per year and participate in 10 hours of continuing nursing education related to systemic therapy per year. Clinical nurse specialists in oncology should only delivery systemic treatment. Specialist trained nurses in the rationale and use of chemotherapy can administer systemic treatment. Must have training in the safe handling and preparation of cytotoxic and hazardous drugs. Nurse’s roles not defined, but only team members who have specialty training in chemotherapy administration can administer systemic treatment. Nurse with chemotherapy training would deliver chemotherapeutic agents. A designated pharmacist shall be appointed the lead and manage the pharmacy according to the prescribed guidelines. Saskatchewan Cancer Agency (23) (2006) BC Cancer Agency (22) (2006) Calman-Hine (26) (1995) Royal College of Physicians (27) (2001) When transferring patient care to the community oncology network, oncologist must ensure the physician has the necessary knowledge and skill to manage the patient. Oncologists in cancer units should have ties and also practice in the larger cancer centres. Clinical and medical oncologists responsible for delivering nonsurgical specialist services. Must have two ½ days in a cancer centre to ensure not working in isolation. Will supervise chemotherapy administration. National Health Service (25) (2004) Barton (29) (2003) Medical Oncology Group of Australia Incorporated (28) (2001) Prescribe, manage and supervise chemotherapy administration. General practitioners Clear roles defined in five different levels of cancer care. To be readily available to assist centre during treatments and for medical emergencies. Provides followup care in consultation with patient’s oncologist. Pharmacy should have proper facilities to mix and reconstitute cytotoxic drugs. Pharmacists should have specialty training. All drugs should be checked by oncology pharmacists. Chemotherapy administered by specialty nurses. EVIDENTIARY REVIEW – page 12 GP’s should follow guidelines in caring for chemotherapy patients, though this point will be difficult to enforce. Registered medical practitioner on call but not necessarily on site. Other support staff Clear roles defined in five different levels of cancer care. Adequate support staff should be available to ensure health records are current and easily accessible. EBS 12-10 Report (reference) Ontario Hôpital Régional de Sudbury Regional Hospital (21) (2005) London Regional Cancer Centre (16) (2006) Thunder Bay Regional Health Science Centre (17-20) (2006) Oncologists Nursing Pharmacists Oncologist at RCP will prescribe therapy Oncologist at London Regional Cancer Centre will prescribe therapy Oncologist at RCP will prescribe therapy Nurses responsible for patient assessment and chemotherapy administration General practitioners Other support staff Will see that patient is fit to receive each cycle of therapy Will assume responsibility for administration and management of adverse effects of systemic treatment Will manage administration of chemotherapy, perform clinical assessment, ensure CCO standards in the administration of chemotherapy are being adhered to, involved in followup care Abbreviations: CCO – Cancer Care Ontario; RCP – regional cancer program. Education of Providers Published Literature While most articles mentioned that specialized health personnel were required to prescribe, prepare, and administer antineoplastic agents, few articles specified what training these health professionals needed. The Cancer Nurses Society of Australia has a comprehensive document that lists the minimum requirements that a nurse must have to administer cytotoxic drugs, including both a theoretical and a clinical education (30). ASC0 (2004) also lists that physicians should acquire training in a formal setting or through a combination of training and experience (9). Nurses should be in compliance with the individual US State practice acts (9). McLinden writes that all nurses who administer chemotherapy must take a chemotherapy course, which can be obtained through distance education. In addition, nurses, family physicians, and pharmacists must all be involved with educational activities hosted through their regional cancer centre during the year (cancer centres host special weekend and teleconference sessions for health professionals in the community) (15). Environmental Scan In their survey of remote and rural oncology services, the Clinical Oncological Society of Australia found that a significant number of nurses in remote areas were administering chemotherapy without the proper education (37). To address this issue of education, the environmental scan produced several documents providing very detailed lists of competencies, accompanied by checklists of what training a nurse needed before being permitted to administer systemic treatment (22,25,35,36). Several documents also stated that nurses and oncologists must be provided with access to continuing medical education classes (24,29,35,39). Environmental Scan - Ontario Five documents from Ontario addressed provider education (16,21,31-33). With respect to nursing education, the Memorandum of Agreement between the London Regional Cancer EVIDENTIARY REVIEW – page 13 EBS 12-10 Centre and Huron Perth Hospitals Partnership and Wingham and District Hospital and Stratford General Hospital requires that nurses successfully complete a closed-book chemotherapy certification course and receive at least 85% as their final mark (16). The Hôpital Régional de Sudbury Regional Hospital requires that all nurses have a certification of competence from the College of Nurses of Ontario and that they renew the chemotherapy certification yearly (21). The Southwest Region Cancer Plan requires that nurses be enrolled in and certified by the Canadian Intravenous Nurses Association (CINA) (31). The Ottawa Hospital Regional Cancer Centre requires nurses to be certified in chemotherapy, with annual recertification. In addition, nurses must continue their professional development, as demonstrated by an annual written current learning plan and membership in an oncology professional organization, and are encouraged to attend at least one oncology-related seminar every two years (33). Pharmacists and technicians must also have proper training. The Memorandum of Agreement between the London Regional Cancer Centre and Huron Perth Hospitals Partnership and Wingham and District Hospital and Stratford General Hospital requires that pharmacy technicians must complete, and receive 100%, on an open-book chemotherapy certification course (16). The Hôpital Régional de Sudbury Regional Hospital requires that pharmacists be licensed with the Ontario College of Pharmacy, have hospital pharmacy experience, and spend one day at the cancer centre to receive basic training, and they are encouraged to attend continuing education seminars (21). The Cancer Centre of Southeastern Ontario outlines the education that pharmacists should have and requires that pharmacists be licensed with the Ontario College of Pharmacy and have hospital pharmacy experience (particularly intravenous [IV] admixture), comprehensive knowledge of pharmaceuticals, and patient counselling experience. They must also be aware of safe-handling procedures and attend continuing oncology education seminars (32). The Ottawa Hospital Regional Cancer Centre requires that pharmacists must have hospital pharmacy experience, and receive basic training by spending one day at the cancer centre; continuing education is encouraged (33). Only the Memorandum of Agreement between the London Regional Cancer Centre and Huron Perth Hospitals Partnership and Wingham and District Hospital and Stratford General Hospital outlines the training and education requirements of physicians. Community physicians who agree to supervise chemotherapy delivery must attend a workshop at the London Regional Cancer Centre. Upon successful completion of this course, the director of the London Regional Cancer Centre will provide written notice that the community physician is prepared to begin the supervision of chemotherapy delivery. Ongoing education is also encouraged for all staff (16). All centres encourage their medical staff to participate in continuing educational activities (16,21,31-33). Service Type/Complexity Published Literature Two reports described the level and complexity of services that can be offered at different centres (8,13). Parrish (13) reported on the types of chemotherapy drugs that the rural Scioto Memorial Hospital (US) is able to administer. The Scioto Memorial Hospital has work forms that list what adverse events need to be checked for, what laboratory tests need to be completed, and what the proper dose to administer is. If patients require other chemotherapy regimens, they must travel to the cancer centre. The ASCO statement on the use of outside services to prepare or administer chemotherapy drugs reports on the different service types that can be used (8). This report also lists key points to document when drugs are prepared by outside agencies, including who prepares the treatment, if the staff has proper safety training, if the facility has emergency guidelines, and who is supervising the delivery of the agents. EVIDENTIARY REVIEW – page 14 EBS 12-10 Environmental Scan Table 7 shows reports found through the environmental scan that list levels of service. Table 7: Documents reporting levels of service and complexity - environmental scan. Report (Reference) Specifies different levels of service offered Cancer Care Nova Scotia (24) (2005) Yes - 5 levels of cancer services Community/Home level - oral systemic treatment Basic Level Hospital- Basic chemotherapy may be administered intermediate Level Hospital – chemotherapy where specialized nursing skill may be administered at this site Advanced Level Hospital – systemic treatment given under direct supervision of oncologist Specialized Level Hospital – Regimens that require a specialized facility or resources Saskatchewan Cancer Agency (40) (2006) No BC Cancer Agency (41) (2006) Calman-Hine (26) (1995) Yes – 6 levels. Satellite; Affiliate; Associate; Treatment specific; Cancer Service; Special Circumstance Royal College of Physicians (27) (2001) Barton (29,42) (2003) Medical Oncology Group of Australia Incorporated (28) (2001) Ministry of Health - New Zealand (38) (2006) Specifies what types of systemic treatment or services are available at each type of centre Provides a description of the services available at each level and a detailed list of the kinds of systemic treatment can be delivered at each level Lists approved drugs that COPS centres can administer No Yes – Provides differences between Cancer Units and Cancer Centres A cancer unit would normally be a district hospital providing a range of cancer services. Would provide care for common cancers. A cancer centre would have a high degree of specialization and comprehensive provision of cancer care. Cancer Centres serve a population of at least 1,000,000 Yes – Builds on Calman-Hine document and provides greater detail in differences between Cancer Units in smaller cities and Cancer Centres in larger cities. Type I cancer unit serves a population of 250,000 and has a long travel time to the larger cancer centre. It has a designated ward for cancer patients Type II cancer unit serves a population of 250,000 and is a short distance from a large cancer centre. This unit provides no beds for inpatients Type III cancer unit is for a small catchments area near the large cancer centre. This centre often only provides chemotherapy 5 levels of services Level 1 cancer service – provide chemotherapy using pre-ordered materials. No dose adjustment. Level 2 cancer service – Nurse with specific chemotherapy training would be on site. Administration, and preparation of chemotherapy is possible Level 3 cancer service –same as level 2, with addition of surgical oncology services and CT scanning Level 4 cancer service –same as level 3, with addition of radiotherapy services on site Level 5 cancer service –same as level 4, with addition of radiation and surgical specialist services. Has paediatric facilities Lists two types of services for rural areas: Requirements for a sustainable resident specialist service in medical oncology and requirements for a sustainable outreach service in medical oncology List differences in service between types of centres Regional clinics outside of cancer centres responsible for administering chemotherapy Includes list of cancer drugs that should be available in cancer treatment centres EVIDENTIARY REVIEW – page 15 List differences in service between types of centres Provides brief description of services offered at each centre Lists service requirements for both types of rural cancer clinics EBS 12-10 Report (Reference) Thunder Bay Regional Cancer Care (39) (2006) Specifies different levels of service offered No Specifies what types of systemic treatment or services are available at each type of centre Yes – Provides lists of drugs that can be delivered at different sites Abbreviations: COPS – Community Oncology Program – Saskatchewan; Service Volumes Published Literature Four articles provided details on service volumes (10,12,15,43). Stevenson et al reported on a consensus study that was undertaken in northeastern Scotland. The consensus agreement was that two nurses trained in chemotherapy administration were required in each facility that delivers chemotherapy, although no mention was made of patient volumes at the centre. The two chemotherapy-trained nurses were required to sufficiently cover the clinic and to make sure that there was no disruption in service during vacation or sickness (43). MacBride reported that, in a nurse-led chemotherapy unit in the Western General Hospital in Scotland, thirteen full-time nurses care for 1,300 patients a month, performing 1,200 procedures (10). McCavana stated that a Macmillan nurse (a special cancer nurse in the UK) and a ward sister cared for 12 patients at any one time at the Lorn Islands District General hospital in Scotland (12); there was no mention of whether these patients were outpatients. McLinden wrote that two family physicians with extra training in oncology should be available at each community clinic. In addition, he noted that the number of nurses at each clinic might differ and was dependant on patient volumes, but this was not specified in any more detail in the article (15). Environmental Scan The environmental scan produced four documents that reported on volumes (25,27,34,44). The Community Oncology Program in Saskatchewan has personnel recommendations for their program. A minimum of two chemotherapy-certified RNs and one licensed pharmacist, a physician available to respond to emergencies, psychosocial support, and clerical support are required in each centre (34). The BC Cancer Agency has a funding formula that a community cancer centre can use to determine the minimum amount of staff required. This formula, which takes into account patient education and scheduling, treatment and support, and rehabilitation, was derived from a provincial survey of the staff that care for cancer patients (44). The Manual for Cancer Services (UK) specifies that there should be an arrangement involving the Head of Service, the oncology pharmacy, and the lead chemotherapy nurse to limit the number of chemotherapy patients when those three judge the workload to have reached unsafe numbers (25). There should also be a policy that states when it is acceptable to deliver chemotherapy outside of normal working hours (25). This document only suggests policies or measures that should be in place and does not provide any details or define any terms. The Royal College of Physicians’ Working Party report (UK) on cancer units has a section on workload estimates. For a type I cancer unit that serves a population of 250,000 and is a far distance from the larger cancer centre, twelve oncologists would be required. For a type II cancer unit that also serves a large population (250,000) but is a short distance from a large cancer centre, 10 oncologists would be required. For a type III cancer unit that serves a small population and is a short distance from the larger cancer centre four oncologists are required (27). EVIDENTIARY REVIEW – page 16 EBS 12-10 Environmental Scan - Ontario Four reports in Ontario addressed service volumes. Both the Southwest Regional Cancer Plan and the Memorandum of Agreement from the Hôpital Régional de Sudbury Regional Hospital recommend that two nurses be trained to administer chemotherapy in a community setting. (21,31) The Cancer Centre of Southeastern Ontario recommends that there be one full-time nurse per 1,700 systemic-suite visits, one pharmacist for 6,000 systemic-suite visits, and one pharmacy technician per 11,500 IV chemotherapy prescriptions (32). While the Ottawa Regional Cancer Centre does not provide a minimum number of chemotherapy administration volumes, it does state that the volumes will be determined by the Centre and the referring institution and be dependant on the resources available to both parties (33). Quality Assurance and Safety Published Literature Quality assurance and safety were addressed in five reports (8,9,11,30,45). Mahoney et al reported that in their hospital setting all adverse drug reactions were to be reported and reviewed in accordance with the hospital adverse drug reaction policy (11). In addition, a hospital-wide quality assurance policy would be established to review compliance with the institution’s “Cancer Chemotherapy Clinical Practice Standard” (11). Both the ASCO special articles addressed quality and safety in their standards for antineoplastic therapy in facilities providing cancer care. The standards include complying with federal Health and Safety Acts, having extravasation and dosing policies, and having properly trained and licensed professionals prescribe, prepare and, administer the drugs (8,9). McCarthy et al, in their survey of rural and remote health agencies in Queensland, observed that, out of 62 nurses, 13% (n=8) reconstituted or mixed the chemotherapy drugs that they were administering (45). To address this health and safety issue, McCarthy et al stated that Australia would make the Cancer Nursing Society of Australia guidelines for cytotoxic administration mandatory in every healthcare facility. The Society guidance document deals with a minimum list of health and safety guidelines for facilities that handle cytotoxic drugs (30). Environmental Scan Five documents reported on quality and safety issues (24,25,28,34,47). The Manual of Cancer Services from the National Health Service (NHS) (UK) has the most comprehensive and detailed list of quality and safety guidelines (25). While the NHS does not provide an exact guideline to follow, it recommends that health facilities have protocols in place to ensure quality and safety standards are being met. Three documents provide a brief checklist of quality and safety standards that should be adhered to (24,34,47). The Medical Oncology Group of Australia Incorporated provides a list of established guidelines for handling cytotoxic drugs that are to be adhered to in Australia (28). Environmental Scan - Ontario Thunder Bay Regional Health Sciences Centre has comprehensive policies and procedures relating to chemotherapy safety that encompass the safe handling, preparation, and disposal of cytotoxic agents; the handling of acute exposures; the monitoring of staff dealing with cytotoxic agents; and safe administration (46). The Memorandum of Agreement between the London Regional Cancer Centre and Huron Perth Hospitals Partnership and Wingham and District Hospital and Stratford General Hospital lists a set of safety polices from the London Regional Cancer Centre that includes guidelines for the handling and disposal of hazardous drugs (16). The Hôpital Régional de Sudbury Regional Hospital requires that all chemotherapy be prepared by pharmacy services and that standardized biological safety hoods be used (21). The affiliation agreement from The Cancer Centre of Southeastern Ontario requires that the community hospital involved adhere to the Cancer Care Ontario safe drug handling standards EVIDENTIARY REVIEW – page 17 EBS 12-10 and procedures (32). The Memorandum of Agreement between Hawkesbury General Hospital and the Ottawa Regional Cancer Centre states that Hawkesbury General Hospital is responsible for ensuring that all safety standards and procedures are adhered to but does not describe the standards and procedures (33). Facility Requirements Published Literature The ASCO 2004 report provided information about treatment facility organization (9). The report outlines the physical requirements that each facility should comply with, including sufficient waiting room chairs and enough examining rooms for each physician, appropriate treatment chairs and beds to meet patient needs, privacy when needed for the patient, adequate nurse or physician access, and the storage and preparation of chemotherapy drugs according to accepted protocols. This document was a general overview and did not define any of the terms used. McLinden stated that the following should be present when administering chemotherapy in a community setting: a clean, comfortable area to administer the chemotherapy; a Class IIB biological fume hood; IV pumps; and access to a phone, fax, and computer (15). Environmental Scan Five documents addressed facility requirements (24,25,28,34,48). These reports provided recommendations on the physical space and equipment needed to deliver systemic treatment. The most comprehensive Canadian document listing facility requirements was The Levels of Care for Cancer Systemic Therapy in Nova Scotia Hospitals (24). This document lists exactly what equipment and physical space is needed by a facility for 80-100 administrations annually, providing details and requirements on treatment, clinic, and waiting area space and also the minimum medical equipment and devices required at the unit (24). The Community Oncology Program Centre Annual Site Visit Checklist from the Saskatchewan Cancer Agency (34) and The Medical Oncology Group of Australia Incorporated (28) provide a detailed list of facility requirements such as laboratory and pharmacy facilities, equipment and supplies, physical space requirements such as space to coordinate appointments, and patient educational materials. The Clinical Oncology Patients’ Liaison Group (UK) has published a report on what can be done to make a chemotherapy unit more patient friendly. This report lists many practical suggestions such as having proper signage, having patient education materials available, and having washrooms nearby, as well as enhancing facilities by hanging pictures (48). The Manual for Cancer Services (UK) has measures that specify what should be available in terms of safety equipment and storage at each site administering systemic treatment (25). Environmental Scan - Ontario The Memorandum of Agreement between the London Regional Cancer Centre and Huron Perth Hospitals Partnership and Wingham and District Hospital and Stratford General Hospital has a small section on facility requirements. Dedicated treatment and assessment/consultation space should be provided for cancer patients receiving chemotherapy (16). The Hôpital Régional de Sudbury Regional Hospital and the Ottawa Regional Cancer Centre provides a detailed description of space and furnishing estimates for community oncology clinics. They list essential equipment needed for treatment and clinical spaces and waiting areas, as well as support staff, medical, and other equipment. They also provide a section on recommended equipment for the clinics (21,33). The Cancer Centre of Southeastern Ontario provides a comprehensive list of facility requirements, including treatment and clinic space, support staff, administration, and medical equipment, and other planning considerations (32). EVIDENTIARY REVIEW – page 18 EBS 12-10 Administrative and Organizational Responsibilities Published Literature The ASCO (2004) special article on the criteria for facilities and personnel for the administration of parenteral systemic antineoplastic therapy states that there should be adequate staff to adhere to policies and procedures within the organization and to complete and distribute medical reports, schedule patients, manage the office, order supplies, and take inventory of the drugs (9). There should also be sufficient staff to provide patient education and the staff and equipment to receive emergency medical reports. This consensus document does not define what is meant by ‘adequate’ or ‘sufficient’. Environmental Scan Four reports addressed the need to have clerical and administrative support (23,24,28,34). These documents mention that adequate support staff should be available to help with patient scheduling and for health records maintenance. However, these documents do not define what an “adequate” level of administrative staff would be or how they arrived at this conclusion. Environmental Scan - Ontario The Cancer Centre of Southeastern Ontario states that the data on oncology visits needed to obtain accurate workload information would be submitted to the appropriate national agencies (32). The Ottawa Regional Cancer Centre provides a detailed description of administrative duties that need to be preformed between the regional cancer centre and the clinic, including dictation, transcript and chart preparation, and data reporting requirements (33). DISCUSSION AND CONSENSUS The Regional Models of Care Systemic Treatment Project Team used the modest evidence that was available from the published literature and environmental scan, and their own expert opinion, to reach consensus for the standards on the organization and delivery of systemic treatment in Ontario. The Project Team also conducted a survey of Ontario institutions providing cancer services in 2006, which was considered in developing the standards. Cancer Care Ontario Regional (CCOR) networks had been delivering systemic treatment, particularly in rural areas under a hub-and-spoke model for several years but without regional governance or management authority (50). More recently, RCPs are being developed in Ontario, with accountability agreements and/or formalized regional programs between an RCP and local hospital(s) to ensure and improve equitable access to appropriate evidencebased and co-ordinated cancer services, including systemic treatment, across an identified region. To meet the new regional approach to the delivery of health services, a new integrated regional systemic treatment model is recommended (Figure 1). The goal of this model is to ensure that, regardless of where in the province a patient receives systemic treatment, the same standard of care is guaranteed and that the patient receives appropriate care in the appropriate setting within the appropriate timeframe. A regional program model replaces a hub and spoke model to better reflect the inter-relationships between all partners delivering systemic treatment. In this new model, the Regional Systemic Treatment Program (RSTP) will assume regional leadership for the delivery of systemic treatment with support from CCO. Although most Local Health Integration Networks (LHINs) have ICPs, it is important to acknowledge that, to best meet the needs of patients, cross-LHIN collaboration must also be considered in the planning of regional systemic treatment programs. In addition, there are also LHINs without ICPs and, therefore, regional cancer services must be planned through a neighbouring LHIN ICP. Under the RSTP, systemic treatment ICPs, affiliates and satellites will work collaboratively EVIDENTIARY REVIEW – page 19 EBS 12-10 to ensure safe evidence-based care that maximizes the capacity of care given across the region while ensuring appropriate high-quality care. Figure 1. Regional model for quality systemic treatment. Adapted from: Champlain Regional Cancer Surgery Model, 2006 The model is based on a set of key fundamental elements that include: i) standards, guidelines, and clinical pathways ii) performance data linked to quality indicators iii) access to regional multidisciplinary cancer conferences (MCCs) iv) regional programs to implement monitor and evaluate quality indicators related to the delivery of safe, evidenced-based, patient-centred care Standards, Guidelines and Clinical Pathways. The CCO Program in Evidence-Based Care (PEBC) has been instrumental in developing clinical practice guidelines and evidence summaries that provide a synopsis of the evidence available for clinical practice (51). Guideline recommendations are to assist health care providers and the public with appropriate decision making. The implementation of provincial guidelines as the basis for defining standards for regional systemic treatment may be used, in addition to the application of regionally determined standards, policies, and procedures and professional standards. In addition, clinical pathways will assist providers and patients in navigating a complex network of multiple programs and improve the coordination of regional services. The pathway(s) will outline a realistic coordinated plan or routine EVIDENTIARY REVIEW – page 20 EBS 12-10 intervention that is designed to improve the effectiveness of resource utilization and achieve a high quality of care and patient outcomes (52). Quality Indicators. This model reaches beyond traditional organization boundaries. Therefore, to ensure a high-quality and safe program, it will be important to identity such a program, as well as linked quality indicators that may be classified as patient outcomes, including safety, organization outcomes, and overall system outcomes. Multidisciplinary Cancer Conferences. As in the CCO Multidisciplinary Cancer Conference (MCC) Standards (53), the primary function of MCCs is to ensure that there is an option to discuss appropriate diagnostic tests, treatment options, and treatment recommendations for cancer patients in a multidisciplinary forum. This model assumes that MCCs will be accessible for health professionals across a region. In addition to discussion around the model of care, the Working Group focused on appropriate levels of care. The key initial decisions about the number of levels and the corresponding complexity of the levels were discussed in relation to the Nova Scotia document (24), since it was considered the most detailed document with the most relevance to the Ontario cancer system. The complexity of the administration of the treatment and the adverse effects of the drugs were crucial in determining the number of levels. Strict criteria that are not open to interpretation about what each level can and cannot deliver have been determined. The criteria for each level are based on the current organization of services in Ontario. The information produced by a survey of Ontario institutions providing ambulatory systemic treatment in 2006 was also considered in determining the levels. The Working Group decided that the results of the survey would not be added to the document but would be included as an appendix, when available. The survey results may be useful to regions and their respective partners as the standards are implemented and evaluated. In order to accommodate some unusual circumstances, in particular the remoteness of some locations, a statement was included to indicate that innovative strategies might be required to implement the standards. The types of providers and their roles and the education of providers were chosen as the elements that should be dealt with first in the document. The Working Group decided these elements were the most important since they outlined the responsibilities and education of the providers. There were numerous discussions by the Panel about the role of the family physician and/or internist. The term General Practitioner Oncologist (GPO) was not used because it would not acknowledge the diversity of non-oncology physicians currently working in the province. The types of drugs that could be administered in each level were originally listed under service types and complexity but were moved to an appendix that will be linked to the CCO Drug Formulary on the CCO Web site. This will allow access to updated regimens by disease site. Brief sections on patient education and supportive care were added, since they closely impact on the care and the systemic treatment that patients are receiving. The educational requirements and definitions for pharmacy departments were somewhat challenging for the Working Group as each institution delivering systemic treatment sets its own internal standards for the pharmacists and pharmacy technicians. There has been much discussion by the Group on service volumes. Given the lack of evidence resulting from the scientific literature search and the environmental scan and the difference in geographical areas in Ontario, the Group had difficulty determining the best volumes for each level. After numerous discussions, the Group determined that service volumes should depend on local conditions. A centre should have a sufficient patient volume to maintain competency and safety. This topic itself may be the focus for further research on quality indicators. EVIDENTIARY REVIEW – page 21 EBS 12-10 CONCLUSIONS The standards for systemic treatment delivery in ambulatory centres in Ontario provide a comprehensive regional and provincial framework. These standards have been formed through a combination of evidence and expert consensus. Consensus was achieved through a small Working Group and the larger Regional Models of Care for Systemic Treatment Project Team. The standards outline the four levels of care that are recommended for the delivery of systemic treatment. The standards do not prevent a hospital from moving up to the next level as long as all the requirements are met and this move is agreed to by the RSTP. The role of this document is to provide a framework for all hospitals to meet the same standards and at the same time achieve quality care and service when administering systemic treatment in Ontario. JOURNAL REFERENCE Vandenberg T, Coakley N, Nayler J, DeGrasse C, Green E, Mackay JA, et al. A framework for the organization and delivery of systemic treatment. Curr Oncol. 2009 Jan;16(1):4-15. For further information about this report, please contact: Dr. Ted Vandenberg London Regional Cancer Program London Health Sciences Centre 790 Commissioners Road London, ON N6A 4L6 Email: [email protected] TEL: 519-685-8640 Dr. Maureen Trudeau Cancer Care Ontario 620 University Avenue Toronto, ON M5G 2L7 Email: [email protected] TEL: 416-480-5145 Funding The PEBC is supported by the Ontario Ministry of Health and Long-Term Care through Cancer Care Ontario. All work produced by the PEBC is editorially independent from its funding source. Copyright This report is copyrighted by Cancer Care Ontario; the report and the illustrations herein may not be reproduced without the express written permission of Cancer Care Ontario. Cancer Care Ontario reserves the right at any time, and at its sole discretion, to change or revoke this authorization. Disclaimer Care has been taken in the preparation of the information contained in this report. Nonetheless, any person seeking to apply or consult the report is expected to use independent medical judgment in the context of individual clinical circumstances or seek out the supervision of a qualified clinician. Cancer Care Ontario makes no representation or guarantees of any kind whatsoever regarding their content or use or application and disclaims any responsibility for their application or use in any way. Contact Information For information about the PEBC and the most current version of all reports, please visit the CCO website at http://www.cancercare.on.ca/ or contact the PEBC office at: Phone: 905-527-4322 ext. 42822 Fax: 905-526-6775 E-mail: [email protected] EVIDENTIARY REVIEW – page 22 EBS 12-10 REFERENCES 1. Canadian Cancer Society and National Cancer Institute of Canada. Canadian cancer statistics 2006. Toronto (Canada): National Cancer Institute of Canada; 2006. 2. Treatment Topic Working Group of the Canadian Strategy for Cancer Control-Systemic 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. Therapy Subgroup. Appendix G: Systemic therapy working group report. In: Canadian Strategy for Cancer Control: treatment working group. Final Report 2002 [monograph on the Internet]. Ottawa (Canada): Canadian Strategy for Cancer Control; 2002 [cited 2006 Jun 22] Available from: http://www.cancercontrol.org/cscc/pdf/finaltreatmentJan2002.pdf Herbst RS, Bajorin DF, Bleiberg H, Blum D, Hao D, Johnson BE, et al. Clinical cancer advances 2005: major research advances in cancer treatment, prevention, and screening–a report from the American Society of Clinical Oncology. J Clin Oncol. 2006;24(1):190-205. The Association of Faculties of Medicine of Canada. Annual census of post-M.D. trainees 2005 - 2006. Canadian Post-M.D. Education Registry [monograph on the Internet]. Ottawa (Canada): The Association of Faculties of Medicine of Canada; 2006 [cited 2006 Jul 04]. Available from: http://www.caper.ca/docs/pdf_200506_CAPER_Census.pdf Canadian Labour and Business Centre. Physician workforce in Canada: literature review and gap analysis [monograph on the Internet]. Final report. Ottawa (Canada): Canadian Labour and Business Centre; 2003 [cited 2006 Jul 04]. Available from: http://www.physicianhr.ca/reports/literatureReviewGapAnalysis-e.pdf Cancer Care Ontario. Ontario Cancer Plan 2005-2008 [monograph on the Internet]. Toronto (Canada): Cancer Care Ontario; 2004 Nov [cited 2006 Jun 21] Available from: http://www.cancercare.on.ca/documents/OntarioCancerPlan.pdf O'Brien-Pallas L, Alksnis C, Wang S. Bringing the future into focus. Projecting RN retirement in Canada [monograph on the Internet]. Ottawa (Canada): Canadian Institute for Health Information; 2003 [cited 2006 Nov 20] Available from: http://secure.cihi.ca/cihiweb/dispPage.jsp?cw_page=AR_1023_E American Society of Clinical Oncology (ASCO). American Society of Clinical Oncology statement regarding the use of outside services to prepare or administer chemotherapy drugs. J Clin Oncol. 2003;21(9):1882-3. American Society of Clinical Oncology (ASCO). Criteria for facilities and personnel for the administration of parenteral systemic antineoplastic therapy. J Clin Oncol. 2004;22(22):4613-5. MacBride S. The role of nurses in a nurse-led chemotherapy unit. Oncol Nurs Forum. 1999;26(8):1281. Mahoney CD, Berard CM, Simas EA, Lacroix S, Mahoney G.M. Implementing a chemotherapy practice standard in an integrated health care system. Hosp Pharm. 1998;33(8):954-60. McCavana P, McCavana P. Delivering chemotherapy in rural areas: can it work? Nurs Times. 2000;96(35):35-6. Parrish RH, Parrish RH. Antineoplastic drug-use process at a rural hospital. Hosp Pharm. 1983;18(5):250-1. Smith SM, Campbell NC. Provision of oncology services in remote rural areas: a Scottish perspective. Eur J Cancer Care (Engl). 2004;13(2):185-92. McLinden D. Administering Chemotherapy in a rural setting: description of a successful program. Can J Rural Med. 2001;6(2):123-5. Memorandum of Agreement between London Regional Cancer Centre (Agent for Cancer Care Ontario) and Huron Perth Hospitals Partnership and Wingham and District EVIDENTIARY REVIEW – page 23 EBS 12-10 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. Hospital and Stratford General Hospital [unpublished monograph]. 2006 [received 2006 Jul 04]. Thunder Bay Regional Cancer Care. Chemotherapy for malignancy-care of the adult & pediatric patient receiving chemotherapy on service. 2006. Thunder Bay Regional Cancer Care. Chemotherapy for malignancy: Care of the adult patient receiving chemotherapy off service [unpublished monograph]. 2006 [received 2006 Jul 04]. Thunder Bay Regional Health Sciences Centre. Chemotherapy I.V. administration [unpublished monograph]. 2006 [received 2006 Jul 04]. Thunder Bay Regional Cancer Care. Role of family physician(s) in community cancer care [unpublished monograph]. 2006 [received 2006 Jul 04]. Hôpital de Régional de Sudbury Regional Hospital. Memorandum of Agreement [unpublished monograph]. 2005 Apr 1. BC Cancer Agency. Communities Oncology Network [monograph on the Internet]. 2006. [cited 2006 Jul 04] Available from: http://www.bccancer.bc.ca/RS/CommunitiesOncologyNetwork/default.htm Saskatchewan Cancer Agency. Community Oncology Program - centre criteria [unpublished monograph]. 1998 Feb [revised 2002 Jun 27; cited 2006 Jul 04]. Policy No.: PSA 500. Cancer Care Nova Scotia. Levels of care for cancer systemic therapy in Nova Scotia hospitals [unpublished monograph]. 2005 Oct [received 2006 Jul 04] [45 p.] National Health Service (NHS). Manual for Cancer Services 2004 [monograph on the Internet]. London: National Health Service. 2004 [cited 2006 Jul 04] Available from: https://www.dh.gov.uk/assetRoot/04/13/55/96/04135596.pdf Calman K, Hine D. A policy framework for commissioning cancer services: a report by the Expert Advisory Group on Cancer to the Chief Medical Officers of England and Wales [monograph on the Internet]. 1995 Apr [cited 2006 Jul 04]. Available from: https://www.dh.gov.uk/assetRoot/04/01/43/66/04014366.pdf Royal College of Physicians (RCP), Joint Collegiate Council for Oncology. Cancer units; improving quality in cancer care. Online publications: RCP Working Party Reports [monograph on the Internet]. 2000 Dec [cited 2006 Jun 14]. Available from: http://www.rcplondon.ac.uk/pubs/wp_cu_home.htm Medical Oncology Group of Australia, Rural Sub-Committee. Provision of oncology services to rural and remote regions of Australia [monograph on the Internet]. Camperdown (Australia): Clinical Oncological Society of Australia; 2001 Sep [cited 2006 Jul 04]. Available from: htpp://www.moga.org.au/news/documents/RuralPaper.pdf Barton M, Frommer M, Olver I, Cox C, Crowe P, Wall B, et al. A cancer service framework for Victoria and future directions for the Peter MacCallum Cancer Institute [monograph on the Internet]. Sydney (Australia): Collaboration for Cancer Outcomes Research and Evaluation; 2003 Jul [cited 2006 Jul 04]. Available from: http://www.health.vic.gov.au/cancer/docs/vcsffinalreport.pdf Cancer Nurses Society of Australia (CNSA). Position statement on the minimum education and safety requirements for nurses involved in the administration of cytotoxic drugs. Aust J Cancer Nurs. 2003;4(2):22-4. Regional Cancer Services Alliance Southwestern Ontario. Southwestern Region Cancer Plan: business case for the Chatham-Kent Health Alliance complex chemotherapy closer to home initiative. 2006 Apr [final draft] [unpublished monograph]. 2005 [revised 2005 Apr 7; 2006 Apr]. Affiliation agreement for the establishment and maintenance of an oncology clinical between the Board of Governors of the Kingston Hospital and [information not provided] [unpublished monograph]. 2005 [received 2006 Jul 04] [11 p.]. EVIDENTIARY REVIEW – page 24 EBS 12-10 33. Memorandum of agreement between Hawkesbury General Hospital and Ottawa 34. 35. 36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47. 48. Regional Cancer Centre for a community chemotherapy clinic serving the Region of Prescott-Russell Counties [unpublished monograph]. 1998 [modified 1998 Dec 7] [14 p.]. Saskatchewan Cancer Agency. Saskatoon Cancer Centre: Community Oncology Program of Saskatchewan. COPS centre annual site visit checklist [unpublished monograph]. Undated [received 2006 Jul 04] Saskatoon Cancer Agency. Saskatchewan Cancer Centre: Community Oncology Program (COEP) Checklist for certification of cancer chemotherapy administration [unpublished monograph]. 1999 Jan [revised 2004 Aug; received 2006 Jul 04] BC Cancer Agency, Oncology Nursing Services. How to set, up staff and fund a Community cancer centre [monograph on the Internet]. 2006 [cited 2006 Jul 04] Available from: http://www.bccancer.bc.ca/RS/CommunitiesOncologyNetwork/Howtosetupstaffandfunda Communitycancercentre/OncologyNursingServices.htm Clinical Oncological Society of Australia. Mapping rural and regional oncology services in Australia [monograph on the Internet]. Camperdown (Australia): Clinical Oncological Society of Australia; 2006 Mar [cited 2006 Jul 04] Available from: http://www.cosa.org.au/documents/Mapping_regional_oncology_services_MAR06.pdf Ministry of Health. Improving non-surgical cancer treatment services in New Zealand [monograph on the Internet]. Wellington (New Zealand): Ministry of Health; 2001 Jul [cited 2006 Jul 04] Available from: http://www.moh.govt.nz/moh.nsf/ea6005dc347e7bd44c2566a40079ae6f/3b4fd60baa73e aaecc256d4900725bc9?OpenDocument Thunder Bay Regional Cancer Care. Regional Cancer Care (Northwest) cancer drug formulary based on CCO NDFD [unpublished monograph]. 2006 [received 2006 Jul 04] Saskatchewan Cancer Agency. Community Oncology Program of Saskatchewan (COPS): COPS drug administration list [unpublished monograph]. [revised 2005 May; cited 2006 Jul 04]. Policy No.: PSA 500 Appendix A. BC Cancer Agency. Communities Oncology Network - definitions [monograph on the Internet]. 2006 [cited 2006 Jul 04] Available from: http://www.bccancer.bc.ca/RS/CommunitiesOncologyNetwork/Definitions.htm Barton M, Frommer M, Olver I, Cox C, Crowe P, Wall B, et al. Cancer services framework highlights report [monograph on the Internet]. Sydney (Australia): Collaboration for Cancer Outcomes Research and Evaluation; 2003 [cited 2006 Jul 04] Available from: http://www.health.vic.gov.au/cancer/docs/cancerhilights.pdf Stevenson L, Campbell NC, Kiehlmann PA. Providing cancer services to remote and rural areas: consensus study [see comment]. Br J Cancer. 2003;89(5):821-7. BC Cancer Agency. How to set up, staff and fund a Community cancer centre- funding formula [monograph on the Internet]. 2006 [cited 2006 Jul 04] Available from: http://www.bccancer.bc.ca/RS/CommunitiesOncologyNetwork/Howtosetupstaffandfunda Communitycancercentre/FundingFormula.htm McCarthy A, Hegney D, Brown L, Gilbar P, Brodribb TR, Swales J. Characteristics of chemotherapy practice in rural and remote area health facilities in Queensland. Aust J Rural Health. 2003;11(3):138-44. Thunder Bay Regional Health Sciences Centre. Chemotherapy safety-infection control policies and procedures. 2002. Saskatchewan Cancer Agency. Provision of cancer chemotherapy in the community [unpublished monograph]. 1998 Feb [revised 2002 Jun 27; cited 2006 Jul 04]. Policy No.: PSA 501. Royal College of Radiologists, Clinical Oncology Patients' Liaison Group. Making your outpatient chemotherapy unit more patient-friendly [monograph on the Internet]. London: EVIDENTIARY REVIEW – page 25 EBS 12-10 49. 50. 51. 52. 53. The Royal College of Radiologists; 2003 Jun [cited 2006 Jul 04] Available from: http://www.rcr.ac.uk/docs/patients/pdf/chemotherapy.pdf BC Cancer Agency. How to set up, staff and fund a Community cancer centre [monograph on the Internet]. 2006 [cited 2006 Jul 04] Available from: http://www.bccancer.bc.ca/RS/CommunitiesOncologyNetwork/Howtosetupstaffandfunda Communitycancercentre/default.htm Ontario Ministry of Health and Long-Term Care. Report of the Cancer Services Implementation Committee [monograph on the Internet]. Toronto (Canada): Ontario Ministry of Health and Long-Term Care; 2001 [cited 2006 Jun 22] Available from: http://www.health.gov.on.ca/english/public/pub/ministry_reports/hudson/hudson.pdf Cancer Care Ontario. About the PEBC and the PEBC reports [monograph on the Internet]. 2006 [cited 2006 Apr 17]. Available from: http://www.cancercare.on.ca/index_practiceguidelinesandEvidencesummaries.htm Smith T, Hilner B. Ensuring quality cancer care by the use of clinical practice guidelines and critical pathways. J Clin Oncol. 2001;19(11):2886-97. Wright F, De Vito C, Langer B, Hunter A, and the Expert Panel on the Multidisciplinary Cancer Conference Standards. Multidisciplinary cancer conference standards [monograph on the Internet]. 2006 Jun 1 [cited 2006 Nov 24]. Available from: http://www.cancercare.on.ca/pdf/pebcmccf.pdf EVIDENTIARY REVIEW – page 26 Evidence-Based Series #12-10: Section 3 Regional Models of Care for Systemic Treatment: Standards: Development and External Review—Methods and Results T. Vandenberg, M. Trudeau, N. Coakley, J. Nayler, C. DeGrasse, E. Green, J.A. Mackay, C. McLennan, A. Smith, L. Wilcock, and the Regional Models of Care Systemic Treatment Project Team A Special Project of the Systemic Treatment Program, Cancer Care Ontario, and The Program in Evidence-based Care, Cancer Care Ontario Report Date: May 22, 2007 THE SYSTEMIC TREATMENT PROGRAM AND THE PROGRAM IN EVIDENCE-BASED CARE COLLABORATION The Systemic Treatment Program and the Program in Evidence-based Care (PEBC) are initiatives of Cancer Care Ontario (CCO). The mandate of the Systemic Treatment Program is to improve the delivery of systemic treatment in Ontario through initiatives designed to increase access to care, improve the quality of care, support knowledge transfer and evidence-based practice and foster research and innovation. The mandate of the PEBC is to improve the lives of Ontarians affected by cancer, through the development, dissemination, implementation, and evaluation of evidence-based products designed to facilitate clinical, planning, and policy decisions about cancer care. The PEBC is best known for producing high-quality evidence-based practice guideline reports, using the methods of the Practice Guidelines Development Cycle (1,2). A typical PEBC report consists of the comprehensive systematic review of the clinical evidence on a specific cancer-related topic, the interpretation of and consensus agreement on that evidence, the resulting clinical recommendations, and the results of an external review by Ontario clinicians for whom the topic is relevant. The PEBC has a formal standardized process to ensure the timeliness of each clinical practice guideline report, conducting routine periodic reviews and evaluations of the scientific literature and, where appropriate, integrating that literature with the original practice guideline report information. This standards report, developed through collaboration between the Systemic Treatment Program and the PEBC, employed a similar process, incorporating an environmental scan of documents from other organizations and jurisdictions within the systematic review process. The report was developed by a specially convened panel, the Regional Models of Care Systemic Treatment Project Team, which comprises medical oncologists, a CCO Regional Vice President, regional cancer program administrators, a systemic treatment satellite nursing administrator, nurses, administrators, pharmacists, research coordinators, and other professionals. DEVELOPMENT AND METHODS – page 1 EBS 12-10 The Evidence-based Series This evidence-based series is comprised of the following three sections: Section 1: Standards This section contains the standards derived by the Regional Models of Care Systemic Treatment Project Team through systematic review, an environmental scan, interpretation of the clinical and scientific literature and expert consensus process, as well as through a formalized external review by Ontario practitioners and administrators. Section 2: Evidentiary Review This section presents the comprehensive systematic review of the clinical and scientific research, the environmental scan and team discussion on the topic and the conclusions drawn by the Regional Models of Care Systemic Treatment Project Team. Section 3: Methodology of the Standards Development and External Review Process This section summarizes the standards development process and the results of the formal external review by Ontario practitioners and administrators of the draft version of the systemic treatment standards and systematic review. DEVELOPMENT OF THE EVIDENCED-BASED SERIES Developing the Draft Systematic Review and Standards This evidence-based series was developed by the Regional Models of Care Systemic Treatment Project Team. The report is a convenient and up-to-date source of the best available evidence developed through systematic review, expert consensus, evidence synthesis, and input from practitioners and administrators in Ontario. Section 2 contains the systematic review of the evidence related to the organization of ambulatory systemic treatment delivery. The draft standards derived from the interpretation of that evidence and the expertise of the members of the Project Team are detailed in Section 1. Sections 1 and 2, along with Section 3, have been circulated to Ontario practitioners and administrators for their feedback. Section 3 now presents the feedback process results and any resulting changes made to the draft document. REPORT APPROVAL PANEL REVIEW A draft of the evidence-based series was circulated to the two members of the Report Approval Panel (RAP) and the Scientific Manager of the PEBC in December 2006. Feedback was provided by the Panel and the Scientific Manager and is summarized below. The feedback was reviewed by the Regional Models of Care Group, and modifications were made to the series in response (see modifications below). Summary of Written Comments with Modifications/Actions Taken by the Regional Models of Care Group The introduction section on regional models of care in section one was unintuitive and difficult to follow. o The section was revised and reorganized to improve clarity. The nuances between the descriptions of the levels were difficult to understand. o To improve clarity, the levels of care in section 1 were further defined. It was suggested to add the levels to figure 1. o Levels were added to the figure 1. At a more specific level, the document appropriately emphasizes a need for institutions to deal with acute reactions to the administration of chemotherapy. This parameter is used to differentiate different institutional Levels. The steering committee may have given undue weighting to this parameter. Dealing with acute reactions (e.g., hypersensitivity, infusional reactions) requires more “general medical” expertise, with focused clinical knowledge about the agent in question. It is a skill that is very transferable to institutions that do not have DEVELOPMENT AND REVIEW – page 2 EBS 12-10 medical or hematologic oncologists. Of far greater importance is the process to define and systematically implement best practices o The levels were reorganized, with the lowest level 5 removed. The only differentiating factor between level 4 and 5 was the ability to deal with acute reactions. “Research” is listed only for Level 1. As clinical trials form a major part of the research agenda, the committee should rephrase as this type of research is conducted across many Level 2 and all Level 1-2 institutions. The committee later acknowledges the broader range of setting for clinical trials, but underestimates the potential for selected IND trials in Level 4 institutions. o The ability to do clinical trials has been moved to level 4. It will depend on the investigators and staff in each institution if they wish to participate in clinical trials. It is not clear why Advanced Practice Nurses would not develop important roles within Level 3. o The document was changed to reflect that Advanced Practice Nurses can work in any level, but they are required in levels 1 and 2. How will the formulary be kept up to date? o The appendix will be updated by the CCO formulary and eventually will be replaced with a hyperlink. REVIEW BY REGIONAL MODELS OF CARE PROJECT TEAM The Project Team met to review the report prior to the external review in March 2007, and had many of the same comments as did RAP. They have previously been addressed and will only be listed here. The introduction to the regional models of care should be rewritten to effectively capture the goals and direction of the systemic treatment program. It was recommended that Level 5 should be merged with Level 4 as they are basically the same except for the ability to give the first dose and respond to acute reactions. Since we received two comments on this, we took action, as previously discussed, and merged the two Levels. Research and academic teaching should also be a part of Levels 2 and 3 to some extent, but it should be acknowledged that research and academic teaching has a greater role in level 1 facilities. The regional models of care diagram (Figure 1) should be revised to show the relationship to the RCP as well. Clinical trials should be done at lower levels as well. Questions arose how the appendices relating the drug formulary in section one would be updated. In May 2007, following the external review, the Project Team discussed and approved the revised report. The Team discussed the external review results and their responses to the external review feedback are detailed below. In addition, the Team agreed that an explicit statement should be added to the report to clarify that the standards do not apply to home or inpatient infusions. The need for Computerized Physician Order Entry (CPOE) was discussed extensively by the Team. It was acknowledged that the cost of implementing CPOE may be prohibitive for smaller centres, particularly in the short-term; however, the potential advantages with regard to patient safety were considered primary. It was noted that in some regions, smaller centres are able to access centralized CPOE systems remotely, although they cannot enter new orders. It was agreed that obtaining CPOE should be a priority during the standards DEVELOPMENT AND REVIEW – page 3 EBS 12-10 implementation phase and required at all levels of care; therefore, the Standards for Facility Requirements were revised accordingly. The implementation and funding support for the standards were also a focus of discussion. It was considered important to allow some flexibility around the implementation process and to provide a forum for institutions and regions to share feedback on implementation issues and experiences. Similarly, provision of appropriate resources was considered central to the achievement of the standards province-wide. Separate CCO panels have responsibility for driving the implementation and funding processes. EXTERNAL REVIEW Feedback was obtained through a mailed survey of 191 practitioners and administrators in Ontario (primarily medical oncologists, nurses, pharmacists, general practitioners of oncology, hospital CEOs and administrators and Local Health Integration Network CEO’s). The survey consisted of items evaluating the methods, results, and interpretive summary used to inform the draft standards and whether the draft standards should be approved as a provincial guidance document. Clinicians and administrators received separate surveys. Clinicians received a longer survey with some questions pertaining to the applicability of the standards in their clinical practice. Both versions of the survey provided opportunity for written comments. The external review was mailed out during the week of March 5, 2007. Follow-up reminders were sent at two weeks (post card) and four weeks (complete package mailed again). The Systemic Treatment working group reviewed the results of the survey. Sixty-six responses were received out of the 191 surveys sent (34% response rate). Of the 66 respondents, 56 completed the questionnaires (29%), and 35 provided written comments. Three respondents who did not complete the survey provided written comments only. A total of 38 written comments were received. Table 1. Participant responses (N=44) to clinician external feedback survey questions (n = 19). 1. 2. Are you responsible in some way for the care of patients diagnosed with cancer? This may include direct clinical care or the organization/management of services to provide care to these patients. 6. There is a need for a standards document on this topic. The evidence (literature search and environmental scan) is relevant and complete (e.g., no key information sources or studies missed nor any included that should not have been). I agree with the methodology used to summarize the evidence. The draft standards are in agreement with my understanding of the evidence. The draft standards in this report are clear. 7. I agree with the draft standards as stated. 3. 4. 5. 8. The draft standards are suitable for the Ontario context. 9. The draft standards are too rigid to apply in the Ontario context. 10. When applied, the draft standards will produce more benefits for patients than harms. Yes Unsure No 44 0 3 Strongly Agree/ Agree Neither Agree nor Disagree Strongly Disagree or Disagree 41 0 3 34 8 1 40 3 1 35 8 1 40 39 1 0 3 5 38 3 3 10 9 25 36 5 3 DEVELOPMENT AND REVIEW – page 4 EBS 12-10 11. The draft standards report presents a series of options that can be implemented. 12. To apply the draft standards will require reorganization of services/care in my practice setting. 13. The standards will be associated with more appropriate utilization of health care resources. 14. The draft standards in this report are achievable. 15. The draft report presents standards that are likely to be supported by a majority of my colleagues. 16. The draft standards reflect a more desirable system for improving the quality of patient care than current practice. 17. I would feel comfortable if patients received the care recommended in these draft standards. 18. These draft standards should be formally approved. 31 7 5 19 12 13 25 15 4 33 8 3 37 5 2 35 6 3 39 3 2 36 4 3 Unsure Not at All/Not Likely 5 6 Likely/Very Likely 19. If these draft standards were to be approved and endorsed, how likely would you be to apply the recommendations to the clinical care or 33 organizational and/or administrative decisions for which you are professionally responsible? * Where percentages total <100%–practitioner response(s) missing. Table 2. Participant responses (N=12) to administrator external feedback survey questions (n = 7). 1. Are you responsible in some way for the care of patients diagnosed with cancer? This may include direct clinical care or the organization/management of services to provide care to these patients. 2. There is a need for standards on this issue. 3. The standards are clear. 4. The standards will be challenging to implement in my institution or region. 5. The standards will be supported by stakeholders in my institution or region 6. The draft standards reflect an effective approach that will lead to quality improvements in patient care 7. The standards reflect an effective approach that will lead to quality improvements in the cancer system. Yes Unsure No 12 0 5 Strongly Agree/ Agree Neither Agree nor Disagree Strongly Disagree or Disagree 12 11 0 1 0 0 4 4 4 10 2 0 11 1 0 10 2 0 * Where percentages total <100%–practitioner response(s) missing. Clinical Respondents The items that 80% or more clinical respondents agreed to were the rationale and need for systemic treatment standards in Ontario, the methodology used, the clarity of the standards report, agreement with the standards as stated, the suitability and acceptability for the standards in Ontario, a more effective approach for improving patient outcomes, the support of a majority DEVELOPMENT AND REVIEW – page 5 EBS 12-10 of colleagues accepting the standards and their comfort if patients received care recommended in these standards. The items that 70% of the respondents agreed to were that the literature search and environmental scan were complete, the standards were in agreement with their understanding of the evidence, the standards represent a series of options that can be implemented and are achievable and that standards reflect a more desirable system for improving patient care. Half of the respondents agreed that the standards would not be too rigid to apply, but would also require service re-organization when applied, and that the standards would reflect a more effective use of resources. In terms of formal approval as a CCO standards document, 81% of respondents agreed that the document should be formally approved, 9% were unsure, and 6% disagreed with formal approval. Approximately 75% of respondents agreed with the statements that they or their centre would be likely to apply the standards if formally approved. The remaining respondents were either unsure (11%) or disagreed with the statements (13% respectively). Administrator Respondents The items that 80% or more of administrators agreed with were the rationale and need for systemic treatment standards in Ontario, the clarity of the standards report, that the standards would be supported by stakeholders in their region, and that these standards will lead to quality improvements in patient care and in the cancer system. One third of the respondents stated that the standards would not be too challenging to apply in their health care setting. Several of the respondents provided written comments. The major themes emerging from the comments provided by the respondents included: Support for the document or the process of standardizing systemic treatment in Ontario. Questions arising about the implementation of this standard, including funding and human resource issues. o Issues surrounding implementation will be addressed by Cancer Care Ontario. Comments about the low-quality evidence for this review. o The group made it clear in the document that the evidence was modest and the standards were based on expert opinion. Comment about smaller centres not wanting to take on complex cases. o The can be addressed through negotiation with the RSTP. College of Nursing literature not cited in the document. o The literature is cited in section one of the document. Comment about clarification that the central venous access devices would be inserted outside the affiliate institution. o The site is responsible for coordination and the insertion can be done at an off site institution. Duplication of some syntax in recommendations. o Corrected. Request for additional clarity around academic and research responsibilities around roles and responsibilities pertaining to clinical trials and leadership of MCCs. o The group felt it was not its job to be prescriptive, and this was adequately covered in the document. Concern for smaller centers having the ability to meet the requirements in the standards without adequate support or resources. o This will be addressed in the implementation and funding documentation by Cancer Care Ontario. DEVELOPMENT AND REVIEW – page 6 EBS 12-10 The guidelines will limit the ability to provide one stop shopping and increase fragmentation of care. o This will be also addressed in the implementation and funding documentation by Cancer Care Ontario. Concern for the level assigned to each centre; some may feel downgraded. o There are four levels of care, determined by resources. The group felt that this issue was outside the scope of this report. Comments about a few specific drugs in the formulary. o Revised. These points were brought back to the working group for discussion, and modifications were made as necessary. Lengthy discussions from the working group arose about the comments, but the group did not feel the need to change the document except to provide greater clarity and corrections to the formulary. The scope of this document was not to be specific or prescriptive. This standards document will provide an important source of information for regional and provincial planning of systemic treatment services. While an implementation plan is beyond the scope of the current document, the use of guidelines and standards is fundamental to the success of Cancer Care Ontario's quality improvement initiatives. An implementation strategy surrounding these standards will be provided by Cancer Care Ontario. This will include, but will not be limited to, knowledge transfer, assessment, planning, evaluating outcomes, funding, and adherence to the standards and support during the transition phase. Conclusion This report reflects the integration of feedback obtained through the external review process with, final approval given by the Systemic Treatment Group and the Report Approval Panel of the PEBC. Updates of the report will be conducted as new evidence informing the question of interest emerges. DEVELOPMENT AND REVIEW – page 7 EBS 12-10 For further information about this report, please contact: Dr. Ted Vandenberg London Regional Cancer Program London Health Sciences Centre 790 Commissioners Road London, ON N6A 4L6 Email: [email protected] TEL: 519-685-8640 Dr. Maureen Trudeau Cancer Care Ontario 620 University Avenue Toronto, ON M5G 2L7 Email: [email protected] TEL: 416-480-5145 Funding The PEBC is supported by the Ontario Ministry of Health and Long-Term Care through Cancer Care Ontario. All work produced by the PEBC is editorially independent from its funding source. Copyright This report is copyrighted by Cancer Care Ontario; the report and the illustrations herein may not be reproduced without the express written permission of Cancer Care Ontario. Cancer Care Ontario reserves the right at any time, and at its sole discretion, to change or revoke this authorization. Disclaimer Care has been taken in the preparation of the information contained in this report. Nonetheless, any person seeking to apply or consult the report is expected to use independent medical judgment in the context of individual clinical circumstances or seek out the supervision of a qualified clinician. Cancer Care Ontario makes no representation or guarantees of any kind whatsoever regarding their content or use or application and disclaims any responsibility for their application or use in any way. Contact Information For information about the PEBC and the most current version of all reports, please visit the CCO website at http://www.cancercare.on.ca/ or contact the PEBC office at: Phone: 905-527-4322 ext. 42822 Fax: 905-526-6775 E-mail: [email protected] DEVELOPMENT AND REVIEW – page 8 EBS 12-10 REFERENCES 1. Browman GP, Levine MN, Mohide EA, Hayward RSA, Pritchard KI, Gafni A, et al. The practice guidelines development cycle: a conceptual tool for practice guidelines development and implementation. J Clin Oncol. 1995;13:502-12. 2. Browman GP, Newman TE, Mohide EA, Graham ID, Levine MN, Pritchard KI, et al. Progress of clinical oncology guidelines development using the practice guidelines development cycle: the role of practitioner feedback. J Clin Oncol. 1998;16(3):1226-31. DEVELOPMENT AND REVIEW – page 9 EBS 12-10 Appendix 1. Regional Models of Care Systemic Treatment Project Team members. The following Project Team members were part of the Working Group * Dr. Maureen Trudeau (chair) * Dr. Ted Vandenberg * Cancer Care Ontario London Regional Cancer Program 620 University Avenue London Health Sciences Centre Toronto, ON M5G 2L7 790 Commissioners Road London, ON N6A 4L6 Nadia Coakley * Research Coordinator Program in Evidence-based Care McMaster University 1280 Main Street West, Hamilton, Ontario L8S 4L8 Jeff Nayler (Program Manager) * Cancer Care Ontario 620 University Avenue Toronto, Ontario M5G 2L7 Cathy DeGrasse * Senior Advisor, Regional Cancer Operations The Ottawa Hospital Regional Cancer Centre 501 Smyth Road Box 941 Ottawa, Ontario K1H 8L6 Esther Green* Provincial Head, Nursing & Psychosocial Oncology Cancer Care Ontario 620 University Avenue Toronto, Ontario M5G 2L7 Jean Mackay * Research Coordinator Program in Evidence-based Care McMaster University 1280 Main Street West, Hamilton, Ontario L8S 4L8 Cindy McLennan * Nurse Manager Oncology Renfrew Victoria Hospital 499 Raglan Street North Renfrew, Ontario K7V 1P6 Dr. Anne Smith * Regional Vice-President Cancer Services for Kingston General Hospital Cancer Centre of Southeastern Ontario 25 King Street West Kingston ON K7L 5P9 Laura Wilcock * Oncology Pharmacist Lakeridge Health - Durham Regional Cancer Centre 1 Hospital Court, Oshawa, ON L1G 2B9 Helen Angus VP, Planning & Strategic Implementation Cancer Care Ontario 620 University Avenue Toronto, Ontario M5G 2L7 Dr. Colin Germond Medical Oncologist Leader, Systemic Treatment Program Regional Cancer Program Sudbury Regional Hospital 41 Ramsey Lake Road Sudbury, Ontario P3E 5J1 Tracey Keighley-Clarke Director, Cancer Care Program Royal Victoria Hospital 201 Georgian Drive Barrie, Ontario L4M-6M2 Dr. Jacinta Meharchand Toronto East General Hospital 825 Coxwell Avenue Toronto, Ontario M4C 3E7 Debbie Milliken Director, New Drug Funding Program Cancer Care Ontario 620 University Avenue Toronto, Ontario M5G 2L7 Kamini Milnes Director, Informatics Cancer Care Ontario 620 University Avenue Toronto, Ontario M5G 2L7 DEVELOPMENT AND REVIEW – page 10 EBS 12-10 Susan Pilatzke Director, Oncology Clinical Systems Regional Cancer Care Program Thunder Bay Regional Health Sciences Centre 980 Oliver Road Thunder Bay, ON P7B 6V4 Vincent Pileggi RS McLaughlin Durham Regional Cancer Centre 1 Hospital Court Oshawa, Ontario L1G 2B9 Colin Preyra 172 Palmerston Avenue Toronto Ontario M6J 2J4 Sue Robertson Corporate Director, Regional Cancer Planning Grand River Hospital 835 King Street West, Kitchener, Ontario N2G 1G3 Jillian Ross Director, Clinical Programs Cancer Care Ontario 620 University Avenue Toronto, Ontario M5G 2L7 Dr. Michael Sherar Vice President, Regional Programs Cancer Care Ontario 620 University Avenue, 16th Floor Toronto, ON M5G 2L7 DEVELOPMENT AND REVIEW – page 11